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A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Recruiting

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Guanfacine hydrochloride (TAK-503)

Atomoxetine hydrochloride

Placebo

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Study Part A:

Participant is a male or female aged 6 to 17 years inclusive at the time of consent/assent.
Participant must meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation using the Kiddie-Schedule for Affective Disorders-Present and Lifetime Version (K-SADS-PL) by a trained child and adolescent psychiatrist at screening (Visit 1A).
Participant for whom prior stimulant therapy is not suitable, not tolerated, or shown to be ineffective as determined by investigator clinical assessment and review of the Prior Stimulant Medication Questionnaire (PSMQ) administered during screening (Visit 1A).
Participant has an ADHD-RS-5 total score greater than or equal to (> =) 28 at baseline (Visit 2A).
Participant has a baseline (Visit 2A) CGI-S score > = 4.
Participant who is a female of childbearing potential (FOCP) and postmenarchal must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening (Visit 1A) and a negative urine pregnancy test at baseline (Visit 2A), be nonlactating, and agree to comply with any applicable contraceptive requirements described in the protocol. Female of child bearing potential is defined as any female participant who is at least aged 9 years or younger than 9 years and postmenarchal.
Participants parent or legally authorized representative (LAR) must provide signature of informed consent. Documentation of assent (if applicable) must be provided by the participant indicating that the participant is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
Participant and parent/LAR are willing and able to comply with all the testing and requirements defined in this protocol, including oversight of morning dosing. Specifically, the parent/LAR must be available for the duration of the study to administer the investigational medicinal product (IMP) dose each morning when the participant awakens.
Participant has supine and standing blood pressure (BP) measurements less than the 95th percentile for age, sex, and height at both screening (Visit 1A) and baseline (Visit 2A).
Participant is functioning at an age-appropriate level intellectually, as judged by the investigator.
Participant is able to swallow intact tablets and capsules.

Study Part B:

Female participants of child-bearing potential must have a negative serum β-hCG pregnancy test if a screening visit is conducted and/or a negative urine pregnancy test at baseline and agree to comply with any applicable contraceptive requirements of the protocol. An FOCP is defined as any female participant who is at least aged 9 years or younger than 9 years and postmenarchal.
Participant has a supine and standing BP measurement less than the 95th percentile for age, sex, and height.

Exclusion Criteria:

Study Part A:

Participant has a current, controlled (requiring medication or therapy) or uncontrolled, comorbid psychiatric disorder (except oppositional defiant disorder), including but not limited to any of the following comorbid Axis I and Axis II disorders (the K-SADS-PL should be reviewed to confirm diagnosis, if necessary):
1. Post-traumatic stress disorder (PTSD)
2. Bipolar illness, psychosis, or family history in either biological parent
3. Pervasive developmental disorder
4. Obsessive-compulsive disorder (OCD)
5. Psychosis/schizophrenia
6. Serious tic disorder or a family history of Tourette's disorder
Participant is currently considered to be a suicide risk by the investigator; has made a previous suicide attempt; has a history of, or currently demonstrating, active suicidal ideation.
Participant has a substance abuse disorder as defined by DSM-5 criteria or has been suspected of a substance abuse or dependence disorder (except nicotine) within the past 6 months.
Participant has a clinically important abnormality on the urine drug and alcohol screen (except for the participants current ADHD stimulant, if applicable) at screening (Visit 1A).
Participant has been physically, sexually, and/or emotionally abused.
Participant has any other disorder that as judged by the investigator could contraindicate TAK-503 or confound the results of the safety and efficacy assessments.
Participant has any condition or illness including any clinically significant abnormal laboratory value at screening (Visit 1A) or, if the laboratory test was repeated, at baseline (Visit 2A) that, as judged by the investigator, would be an inappropriate risk to the participant and/or could confound the interpretation of study results.
Participant has current abnormal thyroid function, defined as abnormal thyroid-stimulating hormone and thyroxine at screening (Visit 1A). Treatment with a stable dose of thyroid medication for > = 3 months before screening will be permitted.
Participant has a known history or presence of: malignancy (except nonmelanoma skin cancer), pregnancy, and/or a developmental delay or abnormality associated with growth or sexual maturation delays that are not related to ADHD.
Children aged 6 to 12 years with a body weight less than (<) 25.0 kg or adolescents aged > = 13 years with a body weight < 34.0 kg at screening (Visit 1A) or baseline (Visit 2A).
Participant is significantly overweight based on the Centers for Disease Control (CDC) BMI-for-age sex-specific charts at screening (Visit 1A) or baseline (Visit 2A). For this study, significantly overweight will be defined as a BMI that is greater than the 95th percentile.
Participant has a known history or presence of: structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g. clinically significant heart block or QT interval prolongation), bradycardia, or exercise-related cardiac events including syncope and presyncope.
Participant has clinically significant electrocardiogram (ECG) findings, as judged by the investigator, at baseline (Visit 2A).
Participant has orthostatic hypotension* or a known history of hypertension. (*Orthostatic hypotension is defined as a sustained reduction of systolic blood pressure of at least 20 millimeter of mercury (mm Hg) or diastolic blood pressure of 10 mm Hg within 3 minutes of standing from supine.)
Participant has a known family history of sudden cardiac death or ventricular arrhythmia.
Participant is currently using any medication that violates protocol-specified washout criteria at baseline (Visit 2A), including any ADHD medication or other prohibited medications such as herbal supplements, medications that affect BP or heart rate (HR) or medications that have central nervous system (CNS) effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (i.e., antihistamines).
Participant has a medical condition except ADHD that requires treatment with any medication that affects the CNS.
Participant is female and pregnant or currently lactating.
Participant has taken another investigational product or participated in a clinical study within 30 days before screening (Visit 1A).
Participant does not tolerate or has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride, atomoxetine, or any TAK-503 or atomoxetine drug product component.
Participant has a history of a seizure disorder (except for a single childhood febrile seizure episode that occurred before the age of 3 years)
Participant is well-controlled on his/her current ADHD medication with acceptable tolerability, and the parent/treating physician does not object to the current medication.
Participant has alanine transaminase (ALT) greater than (>) 2*upper limit of normal (ULN) or aspartate aminotransferase (AST) >2*ULN or bilirubin >1.5*ULN at screening.

Study Part B:

Participant failed screening, voluntarily withdrew, or was discontinued from Study Part A for protocol nonadherence, participant noncompliance, or TEAE or SAE.
Participant had any clinically significant TEAE during Study Part A that, as judged by the investigator, would preclude exposure to TAK-503.
Participant has a history of alcohol or other substance abuse or dependence, as defined by DSM-5 (with the exception of nicotine) within the last 6 months.
Participant currently uses any of the prohibited medication or other medications, including herbal supplements, that affect BP or HR or that have CNS effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (i.e. antihistamines) in violation of the protocol-specified washout criteria at baseline.
Participant has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride, or any components found in TAK-503.
Participant has taken any IMP except placebo in Study Part A within the 30 days before baseline of Study Part B (Visit 2B).
Participant is significantly overweight based on the CDC BMI-for-age sex-specific charts at screening. Significantly overweight is defined as a BMI > 95th percentile.
Participant is a child aged 6 to 12 years with a body weight of < 25.0 kg or an adolescent aged > = 13 years with a body weight of < 34.0 kg at screening (Visit 1B)
Participant has any condition or illness including clinically significant abnormal laboratory values at screening which as judged by the investigator would represent an inappropriate risk to the participant and/or confound the interpretation of study results.
Participant is currently considered a suicide risk as judged by the investigator, has previously made a suicide attempt, has a history of, or is currently demonstrating active suicidal ideation. Participants with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the investigator.
Participant has clinically significant ECG findings, as judged by the investigator, at baseline (Visit 2B).
Participant has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g. clinically significant heart block), exercise-related cardiac events including syncope and presyncope, or clinically significant bradycardia.
Participant has orthostatic hypotension or a known history of hypertension. (*Orthostatic hypotension is defined as a sustained reduction of systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of 10 mm Hg within 3 minutes of standing from supine).
Participant has a history of a seizure disorder (except for a single childhood febrile seizure episode that occurred before the age of 3 years) or the presence of a serious tic disorder including Tourette's syndrome.
Participant has a medical condition except ADHD, which requires treatment with any medication that affects the CNS.
Participant has ALT >2*ULN or AST >2*ULN or bilirubin >1.5*ULN at screening.

Sites / Locations

Harmonex Neuroscience ResearchRecruiting
Advanced Research Center, Inc.Recruiting
Sun Valley Research Center, Inc.Recruiting
Alliance ResearchRecruiting
PCSD Feighner Research
Homestead Medical ResearchRecruiting
Clinical Neuroscience Solutions, Inc.Recruiting
Care Research Center, Inc.Recruiting
Clinical Neuroscience Solutions, Inc.Recruiting
AMR Conventions Research, LtdRecruiting
Collective Medical Research LLCRecruiting
Qualmedica Research, LLCRecruiting
Alivation Research, LLC
Center for Psychiatry and Behavioral Medicine, Inc.Recruiting
University of CincinnatiRecruiting
Cutting Edge Research GroupRecruiting
Clinical Neuroscience Solutions, Inc.Recruiting
Family Psychiatry of The WoodlandsRecruiting
Clinical Research Partners, LLCRecruiting
LKH-Klinikum GrazRecruiting
Medizinische Universtität WienRecruiting
ZNA Middelheim
UZ BrusselRecruiting
UPC KU Leuven Afdeling Kinderpsychiatrie ADHD-raadplegingRecruiting
Foyer Saint FrancoisRecruiting
Universitaetsklinikum FreiburgRecruiting
EB FlevoResearchRecruiting
EB UtrechtResearch
Hospital de Cascais - Dr. José de AlmeidaRecruiting
Centro Clinico Academico 2CA Associacao Braga, Hospital de Braga Piso 1, Ala E
Centro Hospitalar Universitario Cova da Beira, E.P.E
Hospital da Senhora da Oliveira Guimarães
Hospital CUF Descobertas
Centro Materno Infantil do Norte (CMIN) Centro Hospitalar Universitario do Porto
Clinica Universidad de NavarraRecruiting
Hospital Universitari Vall d'HebronRecruiting
Clinica Dr. QuinteroRecruiting
Hospital Infanta LeonorRecruiting
Hospital Universitario Fundacion AlcorconRecruiting
Corporacio Sanitaria Parc TauliRecruiting
PRIMA Barn- och Vuxenpsykiatri ABRecruiting
Tayside Children HospitalRecruiting
Lister HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Arm Label

Part A: Guanfacine hydrochloride (TAK-503)

Part A: Atomoxetine hydrochloride

Part A: Placebo

Part B: Guanfacine hydrochloride (TAK-503)

Arm Description

Participants randomized to TAK-503 will receive initial dose of 1 milligram (mg), and up titrated with weekly incremental dose of 1 mg until an optimal dose is reached. Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive 5 to 7 mg TAK-503 oral tablet once daily (QD) for 52 weeks.

Participants who weigh less than (<) 70 kilograms (kg) at baseline will receive active Atomoxetine hydrochloride capsule orally at an initial dose of 0.5 milligram per kilogram (mg/kg) which may be increased to the target dose of 1.2 mg/kg oral capsule QD during the treatment of 52 weeks. Permitted doses of Atomoxetine hydrochloride capsule will be 10, 18, 25, 40, 60, and 80 mg QD. Participants who weigh >= 70 kg at baseline will receive Atomoxetine hydrochloride at an initial dose of 40 mg oral capsule QD which may be increased to 80 mg and then to 100 mg for 52 weeks. The total dose for participants who weigh >= 70 kg at baseline will not exceed 100 mg.

Participants aged 6 to 12 years will receive a dose of 1 to 4 mg tablet of placebo matched to TAK-503 and aged 13 to 17 years will receive 5 to 7 mg tablets of placebo matched to TAK-503 orally QD for first 18 weeks. Participants who weigh < 70 kg at baseline will receive placebo matched to Atomoxetine hydrochloride oral capsule at an initial dose of 0.5 mg/kg which may be increased to the target dose of 1.2 mg/kg QD oral capsule during the treatment of first 18 weeks. Permitted doses of placebo matched to Atomoxetine hydrochloride will be 10, 18, 25, 40, 60, and 80 mg QD and participants who weigh >= 70 kg will receive placebo matched to Atomoxetine hydrochloride at an initial dose of 40 mg QD capsule orally which may be increased to 80 mg and then to 100 mg.

Participants from Part A roll over into Part B, where participants received placebo in Part A will roll over after first 18 weeks and participants received TAK-503 or atomoxetine will roll over after 52 weeks of Part A. During Part B all the participants will receive TAK-503 at an initial dose of 1 mg, and up titrated with weekly incremental dose of 1 mg until an optimal dose is reached. Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive 5 to 7 mg TAK-503 oral tablet QD for 52 weeks of Part B.

Outcomes

Primary Outcome Measures

Change From Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 10

The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. The RTI task of CANTAB involves elements of decision-making and attention as measured by choice accuracy as well as motor responses, by measuring motor and mental response speeds, and assesses movement time, reaction time, response accuracy, and impulsivity. This outcome measure will be assessed at Week 10 in both Part A and Part B of the study.

Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 18

Change From Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 49

Secondary Outcome Measures

Change From Baseline in the Rapid Visual Information Processing (RVP) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. Cognitive domain, sustained attention will be measured by the CANTAB RVP task. RVP measures the ability to sustain attention over time and is a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo-random order at a rate of 100 digits per minute in a box at the center of the screen. Participants are to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen.

Change From Baseline in the Spatial Working Memory (SWM) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments, SWM is a component of cognitive executive function which is measured by SWM task of CANTAB between the errors. The ability to retain spatial information and manipulate remembered items in working memory will be measured with the SWM task of CANTAB which is self-ordered and assesses the individual's ability to strategize heuristically. The test is a sensitive measure of frontal lobe and executive dysfunction.

Change From Baseline in the Stop Signal Task (SST) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. Response control or inhibition cognitive domain will be measured by the CANTAB SST. SST measure response inhibition. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone is present, the participant is not to respond.

Change From Baseline in the Delayed Matching to Sample (DMS) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

The neurocognitive function effects of TAK-503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. Recognition memory of cognition domain will be measured by the CANTAB DMS task. DMS measures both simultaneous matching and short-term visual memory. The participant is shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample.

Tanner Stage in Both Part A and Part B at Specified Time Points

Sexual maturation will be measured by Tanner stage. The stage of puberty or sexual maturation will be evaluated for each participant according to Tanner staging. The Tanner stage for genitals (male, stages I-V), breasts (females, stages I-V), and pubic hair (both sexes, stages I-V) will be documented at the specified times. Tanner staging will be self-assessed. Self-assessment in this study is defined as participants or parents indicating which drawing of the scale corresponds to participants sexual maturation stage at the time of the specific visit.

Number of Participants With Clinically Significant Changes in Vital signs, ECG, Physical Examination

Physical examinations will include height and weight. Growth will be measured by weight, height, and BMI. Body mass index is a measure of body fat based on height and weight. Vital signs will be assessed based on blood pressure, pulse rate, respiratory rate and body temperature in both Part A and Part B. The HR, PR interval, QRS interval, and QT interval will be measured from all ECGs and the QTcB and QTcF assessed at specified time points in both Part A and Part B of the study.

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An Adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the investigational product or medicinal product. TEAEs include both serious and non-serious AEs.

Brief Psychiatric Rating Scale for Children (BPRS-C)

Psychiatric symptoms will be measured by the Brief Psychiatric Rating Scale for Children (BPRS-C) total score. The 21 items of the clinician-rated BPRS-C are grouped into the following 7 scales: depression, anxiety, psychomotor excitation, behavior problems, withdrawal, thinking disturbance, and organicity. Each item of the 21 items is clinician-graded using the following 7-point severity Likert-scale from 0 to 6 (not present=0; very mild=1; mild=2; moderate=3; moderately severe=4; severe=5; extremely severe=6. BPRS-C will be assessed at specified time points in both Part A and Part B.

Columbia- Suicide Severity Rating Scale (CSSRS)

The C-SSRS is a structured tool to assess suicidal ideation and behavior. A maximum of 19 items will be completed as follows: 7 items are required, a potential 10 additional items will be completed upon a positive response to a required item, and 2 items completed if suicide or suicide-like behavior is observed during the interview. The C-SSRS uses dichotomous scales (i e, yes or no), Likert scales, and text or narrative to further describe thoughts or behaviors. C-SSRS Score will be assessed at specified time points in both Part A and Part B.

Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale

UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of TAK-503 such as Increased Duration of Sleep, Asthenia or Lassitude or lncreased Fatigability, Sleepiness or Sedation, and Orthostatic Dizziness. UKU rating scale will be assessed at specified time points in both Part A and Part B.

Pediatric Daytime Sleepiness Scale (PDSS)

Sedative effects will be measured by participant ratings on the Pediatric Daytime Sleepiness Scale (PDSS). The PDSS is a self-reported assessment of daytime sleepiness in children aged 11 to 15 years. PDSS questionnaire was designed to be easy to administer, score, and interpret. Sleepiness-related questions are based on previous research of situations that can be sensitive to sleep loss in this age group. The 8 questions are scored on Likert-scale from 0 to 4 (never=0; seldom=1; sometimes=2; frequently=3; always=4). The total score on the PDSS can range from 0 (never sleepy) to 32 (always sleepy). PDSS will be assessed at specified time points in both Part A and Part B.

ADHD Rating Scale-5 (ADHD-RS-5) Total Score and Subscales

The ADHD-RS-5 (DuPaul et al., 2016) is used widely by mental health, educational, and medical practitioners in screening, diagnosis, and treatment evaluation to determine the frequency and severity of ADHD symptoms and impairments in children and adolescents. Attention-deficit/hyperactivity disorder symptoms is measured by the investigator-administered ADHD Rating Scale-5 (ADHD-RS-5) total score and hyperactivity/impulsivity and inattention symptoms as subscale scores. The ADHD-RS-5 is based on the diagnostic criteria for ADHD as described in the DSM-5 and consists of 2 symptom subscales, inattention and hyperactivity-impulsivity, each with 9 items and a total scale of 18 items. Each item in the subscale is scored with a value ranging from 0 (no symptoms) to 3 (severe symptoms). The total score can range from 0 to 54. ADHD-RS-5 Total Score and Subscales wiil be assessed at specified time points in both Part A and Part B.

Clinical Global Impression-Improvement (CGI-I)

Global clinical measurement of ADHD improvement as measured by Clinical Global Impression-Improvement (CGI-I) using the Clinical Global Impression-Severity (CGI-S) to establish baseline. The CGI scale will be used to evaluate the severity of mental illness over time. The CGI-S will be administered to assess the severity of mental illness at baseline. The CGI-S is scored on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The CGI-I is also scored on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I will be measured at specified time points in both Part A and Part B.

Child Health and Illness Profile - Child Edition: Parent Report Form (CHIP-CE:PRF)

The Parent Report Form of the Child Health and Illness Profile - Child Edition (CHIP-CE:PRF) will be administered to provide information on self-esteem and school functioning in pediatric participants diagnosed with ADHD. The 5 domains and 12 subdomains covered in the 76 items comprising the CHIP-CE:PRF. Satisfaction: with health (7 items) and self (4 items); Comfort: physical (9 items) and emotional symptoms (9 items) and activity restrictions (4 items) due to illness; Resilience: behaviors and family involvement (8 items) in activities likely to enhance health, Social problem-solving (5 items),Physical activity (6 items); Risk avoidance: behaviors that if not avoided are likely to pose risks to health: Individual risk avoidance (4 items), Threats to achievement (10 items); Achievement: developmentally appropriate role functioning in school and with peers: Academic performance (5 items), Peer relations (5 items). CHIP-CE: PRF will be assessed in both Part A and Part B.

Conners 3 Parent Short Form (C3PS) Total Score

The Conners 3 is a focused diagnostic tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS is completed by a child's parent/guardian and is comprised of 45 items with subsets of items related to six content scales: inattention, hyperactivity/impulsivity, executive functioning, learning problems, defiance/aggression and peer relations. The parent rates his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently]) based on past month; the last 2 items are fill-in-the-blank and do not contribute to the raw score(s). Raw scores are converted to T-scores. Lower change from baseline T-scores (<0) represent a better outcome. C3PS Total score will be assessed in both Part A and Part B.

Full Information

NCT ID

NCT04085172

First Posted

September 9, 2019

Last Updated

June 6, 2023

Sponsor

Shire

Collaborators

Takeda Development Center Americas, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04085172

Brief Title

A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)

Official Title

A Phase 4, Multicenter, 2-part Study Composed of a 1-Year Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation Followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attention-deficit/Hyperactivity Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 18, 2019 (Actual)

Primary Completion Date

December 17, 2025 (Anticipated)

Study Completion Date

December 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shire

Collaborators

Takeda Development Center Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The main aim of this study is learn more about long-term treatment of children and teenagers with ADHD for whom earlier stimulant therapy did not work. The study has two parts (A and B). In Part A, participants will take tablets of TAK-503, atomoxetine or placebo. Participants who take placebo tablets in Part A, will take TAK-503 tablets in Part B. Participants who take TAK-503 or atomoxetine tablets in Part A, will be treated with TAK-503 in Part B.

Detailed Description

This study will be conducted in two parts Part A and Part B. Part A is a double-blinded, double-dummy, placebo-controlled study with an atomoxetine arm as an active reference to TAK-503. Eligible participants with ADHD will be randomized in a 1:1:1 ratio among TAK-503, atomoxetine, and placebo treatment arms for the first 18 weeks of double-blinded treatment. At the end of the first 18 weeks, participants in the placebo treatment arm will rollover to Part B of the study directly for an additional 52 weeks of open-label TAK-503 treatment. Participants in the TAK-503 and atomoxetine treatment arms will continue in Part A at the same optimized dose for the remainder of the 52 weeks. At the end of 52 weeks of double-blinded treatment and evaluation in Part A, participants in the TAK-503 and atomoxetine treatment arms will rollover into Part B of the study for an additional 1 year of open-label TAK-503 treatment. 26 JUNE 2020: The temporary enrollment stop of new participants into this study due to the COVID-19 pandemic has been lifted in one or more countries/sites, and the study is now again enrolling new participants. However, some countries/sites may still have paused the enrollment of new participants due to the pandemic. 20 APRIL 2020: Enrollment of new participants into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

This study contains two part (Part A and Part B), where Part A will be double blind, double dummy part of the study followed by Part B as an open label part of the study.

Allocation

Randomized

Enrollment

288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part A: Guanfacine hydrochloride (TAK-503)

Arm Type

Experimental

Arm Description

Arm Title

Part A: Atomoxetine hydrochloride

Arm Type

Active Comparator

Arm Description

Arm Title

Part A: Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Part B: Guanfacine hydrochloride (TAK-503)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Guanfacine hydrochloride (TAK-503)

Other Intervention Name(s)

Intuniv, SPD503

Intervention Description

In both Part A and Part B of the study participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg TAK-503 oral tablets once daily for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

Atomoxetine hydrochloride

Intervention Description

Participants in Part A of the study will receive Atomoxetine hydrochloride oral capsule once daily for 52 weeks.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

In Part A participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg placebo matched to TAK 503 oral tablets once daily for 18 weeks and placebo matched to atomoxetine hydrochloride oral capsules at once daily for 18 weeks.

Primary Outcome Measure Information:

Title

Change From Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 10

Description

Time Frame

Baseline, Week 10

Title

Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 18

Description

Time Frame

Baseline, Week 18

Title

Change From Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 49

Description

Time Frame

Baseline, Week 49

Secondary Outcome Measure Information:

Title

Change From Baseline in the Rapid Visual Information Processing (RVP) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

Description

Time Frame

Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49

Title

Change From Baseline in the Spatial Working Memory (SWM) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

Description

Time Frame

Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49

Title

Change From Baseline in the Stop Signal Task (SST) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

Description

Time Frame

Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49

Title

Change From Baseline in the Delayed Matching to Sample (DMS) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

Description

Time Frame

Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49

Title

Tanner Stage in Both Part A and Part B at Specified Time Points

Description

Time Frame

Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49

Title

Number of Participants With Clinically Significant Changes in Vital signs, ECG, Physical Examination

Description

Time Frame

From start of study drug administration up to follow up (Week 53)

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

From start of study drug administration up to follow up (Week 53)

Title

Brief Psychiatric Rating Scale for Children (BPRS-C)

Description

Time Frame

Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49

Title

Columbia- Suicide Severity Rating Scale (CSSRS)

Description

Time Frame

Baseline (from start of study drug administration) to Week 52

Title

Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale

Description

Time Frame

Part A: Baseline, Week 10, Week 18, Week 23, Week 36, Week 49, Week 50, Week 51 and Week 52 Part B: Baseline, Week 10, Week 23, Week 36, Week 49, Week 50, Week 51 and Week 52

Title

Pediatric Daytime Sleepiness Scale (PDSS)

Description

Time Frame

Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49

Title

ADHD Rating Scale-5 (ADHD-RS-5) Total Score and Subscales

Description

Time Frame

Part A: Baseline, Week 1, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49

Title

Clinical Global Impression-Improvement (CGI-I)

Description

Time Frame

Part A: Week 1, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Week 10, Week 23, Week 36 and Week 49

Title

Child Health and Illness Profile - Child Edition: Parent Report Form (CHIP-CE:PRF)

Description

Time Frame

Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49

Title

Conners 3 Parent Short Form (C3PS) Total Score

Description

Time Frame

Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Study Part A: Participant is a male or female aged 6 to 17 years inclusive at the time of consent/assent. Participant must meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation using the Kiddie-Schedule for Affective Disorders-Present and Lifetime Version (K-SADS-PL) by a trained child and adolescent psychiatrist at screening (Visit 1A). Participant for whom prior stimulant therapy is not suitable, not tolerated, or shown to be ineffective as determined by investigator clinical assessment and review of the Prior Stimulant Medication Questionnaire (PSMQ) administered during screening (Visit 1A). Participant has an ADHD-RS-5 total score greater than or equal to (> =) 28 at baseline (Visit 2A). Participant has a baseline (Visit 2A) CGI-S score > = 4. Participant who is a female of childbearing potential (FOCP) and postmenarchal must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening (Visit 1A) and a negative urine pregnancy test at baseline (Visit 2A), be nonlactating, and agree to comply with any applicable contraceptive requirements described in the protocol. Female of child bearing potential is defined as any female participant who is at least aged 9 years or younger than 9 years and postmenarchal. Participants parent or legally authorized representative (LAR) must provide signature of informed consent. Documentation of assent (if applicable) must be provided by the participant indicating that the participant is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures. Participant and parent/LAR are willing and able to comply with all the testing and requirements defined in this protocol, including oversight of morning dosing. Specifically, the parent/LAR must be available for the duration of the study to administer the investigational medicinal product (IMP) dose each morning when the participant awakens. Participant has supine and standing blood pressure (BP) measurements less than the 95th percentile for age, sex, and height at both screening (Visit 1A) and baseline (Visit 2A). Participant is functioning at an age-appropriate level intellectually, as judged by the investigator. Participant is able to swallow intact tablets and capsules. Study Part B: Female participants of child-bearing potential must have a negative serum β-hCG pregnancy test if a screening visit is conducted and/or a negative urine pregnancy test at baseline and agree to comply with any applicable contraceptive requirements of the protocol. An FOCP is defined as any female participant who is at least aged 9 years or younger than 9 years and postmenarchal. Participant has a supine and standing BP measurement less than the 95th percentile for age, sex, and height. Exclusion Criteria: Study Part A: Participant has a current, controlled (requiring medication or therapy) or uncontrolled, comorbid psychiatric disorder (except oppositional defiant disorder), including but not limited to any of the following comorbid Axis I and Axis II disorders (the K-SADS-PL should be reviewed to confirm diagnosis, if necessary): Post-traumatic stress disorder (PTSD) Bipolar illness, psychosis, or family history in either biological parent Pervasive developmental disorder Obsessive-compulsive disorder (OCD) Psychosis/schizophrenia Serious tic disorder or a family history of Tourette's disorder Participant is currently considered to be a suicide risk by the investigator; has made a previous suicide attempt; has a history of, or currently demonstrating, active suicidal ideation. Participant has a substance abuse disorder as defined by DSM-5 criteria or has been suspected of a substance abuse or dependence disorder (except nicotine) within the past 6 months. Participant has a clinically important abnormality on the urine drug and alcohol screen (except for the participants current ADHD stimulant, if applicable) at screening (Visit 1A). Participant has been physically, sexually, and/or emotionally abused. Participant has any other disorder that as judged by the investigator could contraindicate TAK-503 or confound the results of the safety and efficacy assessments. Participant has any condition or illness including any clinically significant abnormal laboratory value at screening (Visit 1A) or, if the laboratory test was repeated, at baseline (Visit 2A) that, as judged by the investigator, would be an inappropriate risk to the participant and/or could confound the interpretation of study results. Participant has current abnormal thyroid function, defined as abnormal thyroid-stimulating hormone and thyroxine at screening (Visit 1A). Treatment with a stable dose of thyroid medication for > = 3 months before screening will be permitted. Participant has a known history or presence of: malignancy (except nonmelanoma skin cancer), pregnancy, and/or a developmental delay or abnormality associated with growth or sexual maturation delays that are not related to ADHD. Children aged 6 to 12 years with a body weight less than (<) 25.0 kg or adolescents aged > = 13 years with a body weight < 34.0 kg at screening (Visit 1A) or baseline (Visit 2A). Participant is significantly overweight based on the Centers for Disease Control (CDC) BMI-for-age sex-specific charts at screening (Visit 1A) or baseline (Visit 2A). For this study, significantly overweight will be defined as a BMI that is greater than the 95th percentile. Participant has a known history or presence of: structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g. clinically significant heart block or QT interval prolongation), bradycardia, or exercise-related cardiac events including syncope and presyncope. Participant has clinically significant electrocardiogram (ECG) findings, as judged by the investigator, at baseline (Visit 2A). Participant has orthostatic hypotension* or a known history of hypertension. (*Orthostatic hypotension is defined as a sustained reduction of systolic blood pressure of at least 20 millimeter of mercury (mm Hg) or diastolic blood pressure of 10 mm Hg within 3 minutes of standing from supine.) Participant has a known family history of sudden cardiac death or ventricular arrhythmia. Participant is currently using any medication that violates protocol-specified washout criteria at baseline (Visit 2A), including any ADHD medication or other prohibited medications such as herbal supplements, medications that affect BP or heart rate (HR) or medications that have central nervous system (CNS) effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (i.e., antihistamines). Participant has a medical condition except ADHD that requires treatment with any medication that affects the CNS. Participant is female and pregnant or currently lactating. Participant has taken another investigational product or participated in a clinical study within 30 days before screening (Visit 1A). Participant does not tolerate or has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride, atomoxetine, or any TAK-503 or atomoxetine drug product component. Participant has a history of a seizure disorder (except for a single childhood febrile seizure episode that occurred before the age of 3 years) Participant is well-controlled on his/her current ADHD medication with acceptable tolerability, and the parent/treating physician does not object to the current medication. Participant has alanine transaminase (ALT) greater than (>) 2*upper limit of normal (ULN) or aspartate aminotransferase (AST) >2*ULN or bilirubin >1.5*ULN at screening. Study Part B: Participant failed screening, voluntarily withdrew, or was discontinued from Study Part A for protocol nonadherence, participant noncompliance, or TEAE or SAE. Participant had any clinically significant TEAE during Study Part A that, as judged by the investigator, would preclude exposure to TAK-503. Participant has a history of alcohol or other substance abuse or dependence, as defined by DSM-5 (with the exception of nicotine) within the last 6 months. Participant currently uses any of the prohibited medication or other medications, including herbal supplements, that affect BP or HR or that have CNS effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (i.e. antihistamines) in violation of the protocol-specified washout criteria at baseline. Participant has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride, or any components found in TAK-503. Participant has taken any IMP except placebo in Study Part A within the 30 days before baseline of Study Part B (Visit 2B). Participant is significantly overweight based on the CDC BMI-for-age sex-specific charts at screening. Significantly overweight is defined as a BMI > 95th percentile. Participant is a child aged 6 to 12 years with a body weight of < 25.0 kg or an adolescent aged > = 13 years with a body weight of < 34.0 kg at screening (Visit 1B) Participant has any condition or illness including clinically significant abnormal laboratory values at screening which as judged by the investigator would represent an inappropriate risk to the participant and/or confound the interpretation of study results. Participant is currently considered a suicide risk as judged by the investigator, has previously made a suicide attempt, has a history of, or is currently demonstrating active suicidal ideation. Participants with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the investigator. Participant has clinically significant ECG findings, as judged by the investigator, at baseline (Visit 2B). Participant has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g. clinically significant heart block), exercise-related cardiac events including syncope and presyncope, or clinically significant bradycardia. Participant has orthostatic hypotension or a known history of hypertension. (*Orthostatic hypotension is defined as a sustained reduction of systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of 10 mm Hg within 3 minutes of standing from supine). Participant has a history of a seizure disorder (except for a single childhood febrile seizure episode that occurred before the age of 3 years) or the presence of a serious tic disorder including Tourette's syndrome. Participant has a medical condition except ADHD, which requires treatment with any medication that affects the CNS. Participant has ALT >2*ULN or AST >2*ULN or bilirubin >1.5*ULN at screening.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Takeda Contact

Phone

+1 866 842 5335

ClinicalTransparency@takeda.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda Development Center Americas

Official's Role

Study Director

Facility Information:

Facility Name

Harmonex Neuroscience Research

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36303

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

334-836-2000

nhandal@harmonex.us

First Name & Middle Initial & Last Name & Degree

Nelson Handal-Thome

Facility Name

Advanced Research Center, Inc.

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site contact

First Name & Middle Initial & Last Name & Degree

Daniel Johnson

Facility Name

Sun Valley Research Center, Inc.

City

Imperial

State/Province

California

ZIP/Postal Code

92251

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

760-355-0176

bng@sunvalleyb.com

First Name & Middle Initial & Last Name & Degree

Bernardo Ng

Facility Name

Alliance Research

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

562-748-4999

ahilliard@allianceforresearch.com; erowell@allianceforresearch.com

First Name & Middle Initial & Last Name & Degree

Elizabeth Zarate-Rowell

Facility Name

PCSD Feighner Research

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Individual Site Status

Completed

Facility Name

Homestead Medical Research

City

Homestead

State/Province

Florida

ZIP/Postal Code

33030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

786-243-1909

mariadelgadomd@homesteadmedicalclinic.com

First Name & Middle Initial & Last Name & Degree

Maria I. Delgado

Facility Name

Clinical Neuroscience Solutions, Inc.

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

904-281-5757

njones@cnshealthcare.com; mpohle@cnshealthcare.com

First Name & Middle Initial & Last Name & Degree

Nandita Joshi Jones

Facility Name

Care Research Center, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

305-994-7599

lankar@carerc.org

First Name & Middle Initial & Last Name & Degree

Matthew Doty

Facility Name

Clinical Neuroscience Solutions, Inc.

City

Orlando

State/Province

Florida

ZIP/Postal Code

32801

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

407-425-5100

Rmolpus@cnshealthcare.com

First Name & Middle Initial & Last Name & Degree

Robert Bond Molpus, MD

Facility Name

AMR Conventions Research, Ltd

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60563

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

630-983-2000

drgaonkar@hotmail.com

First Name & Middle Initial & Last Name & Degree

Sandeep Gaonkar

Facility Name

Collective Medical Research LLC

City

Prairie Village

State/Province

Kansas

ZIP/Postal Code

66208

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

608-848-8900

mthomas@interspond.com

First Name & Middle Initial & Last Name & Degree

Haydn Thomas

Facility Name

Qualmedica Research, LLC

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42301

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

812-550-3197

drsartore@qualmedicaresearch.com

First Name & Middle Initial & Last Name & Degree

J Christopher Sartore

Facility Name

Alivation Research, LLC

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68526

Country

United States

Individual Site Status

Completed

Facility Name

Center for Psychiatry and Behavioral Medicine, Inc.

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

702-838-0742

Drann87@aol.com

First Name & Middle Initial & Last Name & Degree

Ann Childress

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

513-558-4489

melissa.delbello@uc.edu

First Name & Middle Initial & Last Name & Degree

Melissa P. DelBello

Facility Name

Cutting Edge Research Group

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

405-603-8068

Ext

3201

wholloway@cuttingedgeresearch.org

First Name & Middle Initial & Last Name & Degree

Willis Holloway

Facility Name

Clinical Neuroscience Solutions, Inc.

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

901-843-1045

varnold@cnshealthcare.com

First Name & Middle Initial & Last Name & Degree

Valerie Arnold

Facility Name

Family Psychiatry of The Woodlands

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77381

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

832-616-2674

mlucasmd@woodlandspsych.com

First Name & Middle Initial & Last Name & Degree

Marshall Lucas

Facility Name

Clinical Research Partners, LLC

City

Petersburg

State/Province

Virginia

ZIP/Postal Code

23805

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

804-921-9592

tsimon@clinicalresearchrva.com

First Name & Middle Initial & Last Name & Degree

Thresa H. Simon

Facility Name

LKH-Klinikum Graz

City

Graz

ZIP/Postal Code

8036

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+43 (316) 385 - 83740

Wolfgang.Kaschnitz@medunigraz.at

First Name & Middle Initial & Last Name & Degree

Wolfgang Kaschnitz

Facility Name

Medizinische Universtität Wien

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+43 (0)1 40400-32660

claudia.klier@meduniwien.ac.at

First Name & Middle Initial & Last Name & Degree

Claudia Klier

Facility Name

ZNA Middelheim

City

Borgerhout

ZIP/Postal Code

55 2140

Country

Belgium

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+32 3 270 85 53

dirk.vanwest@zna.be

First Name & Middle Initial & Last Name & Degree

Dirkvan West

Facility Name

UZ Brussel

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+32 2 474 9000

Sara.wouters@uzbrussel.be

First Name & Middle Initial & Last Name & Degree

Sara Wouters

Facility Name

UPC KU Leuven Afdeling Kinderpsychiatrie ADHD-raadpleging

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+3216343821

Marina.danckaerts@upckuleuven.be

First Name & Middle Initial & Last Name & Degree

Marina Danckaerts

Facility Name

Foyer Saint Francois

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+3281708850

Mikael.mathot@uclouvain.be

First Name & Middle Initial & Last Name & Degree

Mikael Mathot

Facility Name

Universitaetsklinikum Freiburg

City

Freiburg

ZIP/Postal Code

79104

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

christian.fleischhaker@uniklinik-freiburg.de

First Name & Middle Initial & Last Name & Degree

Christian Fleischhaker

Facility Name

EB FlevoResearch

City

Almere

ZIP/Postal Code

1311RL

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+31 660030760

m.alhakim@flevoresearch.com

First Name & Middle Initial & Last Name & Degree

Mazin AlHakim

Facility Name

EB UtrechtResearch

City

Utrecht

ZIP/Postal Code

3562KX

Country

Netherlands

Individual Site Status

Completed

Facility Name

Hospital de Cascais - Dr. José de Almeida

City

Alcabideche

ZIP/Postal Code

2755-009

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+351214653000

manuel.sousa.cunha@hospitaldecascais.pt

First Name & Middle Initial & Last Name & Degree

Manuel Cunha

Facility Name

Centro Clinico Academico 2CA Associacao Braga, Hospital de Braga Piso 1, Ala E

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Individual Site Status

Completed

Facility Name

Centro Hospitalar Universitario Cova da Beira, E.P.E

City

Covilhã

ZIP/Postal Code

6200-502

Country

Portugal

Individual Site Status

Completed

Facility Name

Hospital da Senhora da Oliveira Guimarães

City

Guimarães

ZIP/Postal Code

4835-044

Country

Portugal

Individual Site Status

Completed

Facility Name

Hospital CUF Descobertas

City

Lisboa

ZIP/Postal Code

1998-018

Country

Portugal

Individual Site Status

Completed

Facility Name

Centro Materno Infantil do Norte (CMIN) Centro Hospitalar Universitario do Porto

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Individual Site Status

Completed

Facility Name

Clinica Universidad de Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31080

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+ 34 948 296 435

adiezs@unav.es

First Name & Middle Initial & Last Name & Degree

Azucena Diez Suarez

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+34 93 2746087

jaramos@vhebron.net

First Name & Middle Initial & Last Name & Degree

Josep Antoni Ramos Quiroga

Facility Name

Clinica Dr. Quintero

City

Madrid

ZIP/Postal Code

28002

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+34 915637474

fjquinterog@yahoo.es

First Name & Middle Initial & Last Name & Degree

Javier Quintero Gutierrez del Alamo

Facility Name

Hospital Infanta Leonor

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+34 911918952

fernmora@gmail.com

First Name & Middle Initial & Last Name & Degree

Fernando Mora Minguez

Facility Name

Hospital Universitario Fundacion Alcorcon

City

Madrid

ZIP/Postal Code

28922

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+34 916219851

fmontanes@fhalcorcon.es

First Name & Middle Initial & Last Name & Degree

Francisco Montañes Rada

Facility Name

Corporacio Sanitaria Parc Tauli

City

Sabadell

ZIP/Postal Code

8208

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+34937458475

mpamias@tauli.cat

First Name & Middle Initial & Last Name & Degree

Montserrat Pamias Massana

Facility Name

PRIMA Barn- och Vuxenpsykiatri AB

City

Norsborg

ZIP/Postal Code

145 67

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+46 709 73 6662

maibritt.giacobini@prima.se

First Name & Middle Initial & Last Name & Degree

MaiBritt Giacobini

Facility Name

Tayside Children Hospital

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

01382 204004

mbasha@nhs.net

First Name & Middle Initial & Last Name & Degree

Maha Basha

Facility Name

Lister Hospital

City

Stevenage

ZIP/Postal Code

SG1 4AB

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+44(0) 1438288345

Inyang.takon@nhs.net

First Name & Middle Initial & Last Name & Degree

Inyang Takon

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing URL

https://vivli.org/ourmember/takeda/

Links:

URL

https://clinicaltrials.takeda.com/study-detail/5f6b600a4db2bf003ab48b68

Description

To obtain more information on the study, click here/on this link

Learn more about this trial

A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)

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