Back to resultsSafety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder (ADHD)
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SHP465 12.5mg capsules (one capsule daily)
Placebo
SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility Criteria
Inclusion Criteria:
Subject must be 18-55 years of age
Subject is able to provide written, personally signed and dated informed consent.
Subject is willing and able to comply with all of the testing and requirements defined in the protocol
Subject, who is a female, must not be pregnant.
Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities.
Subject has a primary diagnosis of ADHD.
Subject has an adult ADHD-RS with prompts total score ≥28 at the baseline visit.
Subject must have a minimum level of intellectual functioning, as determined by the investigator.
Subject is able to swallow a capsule.
Subject is currently not on ADHD therapy or is not completely satisfied with any aspect of their current ADHD therapy.
Exclusion Criteria:
Subject has a current, comorbid psychiatric diagnosis with significant symptoms.
Subject is considered a suicide risk in the opinion of the investigator
Subject has a body mass index (BMI) of <18.5 kg/m2 at the screening visit.
Subject has a BMI ≥40 kg/m2 at the screening visit.
Subject has a concurrent chronic or acute illness, disability, or other condition.
Subject has a history of seizure, a chronic or current tic disorder, or a current diagnosis of Tourette's disorder.
Subject has a history of moderate to severe hypertension.
Subject has a known history of symptomatic cardiovascular disease
Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
Subject has any clinically significant ECG or clinically significant laboratory abnormality at the screening visit.
Subject has current abnormal thyroid function
Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
Subject has failed to respond, to an adequate course(s) of amphetamine therapy.
Subject has a history of suspected substance abuse or dependence disorder.
Subject has a positive urine drug result at the screening visit (with the exception of subject's current stimulant therapy, if any) or Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the screening visit.
Subject has previously completed, has discontinued, or was withdrawn from this study.
Subject is taking any medication that is excluded or has not been appropriately washed out according to the protocol requirements.
Subject is required to take or anticipates the need to take medications that have CNS effects or affect performance.
Subject is female and is pregnant or lactating.
Sites / Locations
- Pharmacology Research Institute
- Pharmacology Research Institute (Pri)
- Pharmacology Research Institute (Pri)
- Nrc Research Institute
- Elite Clinical Trials
- McB Clinical Research
- Florida Clinical Research Center Llc
- Gulfcoast Clinical Research Center
- Sarkis Clinical Trials
- Clinical Neuroscience Solutions, Inc
- Florida Clinical Research Center, Llc
- Qps Mra, Llc
- Medical Research Group of Central Florida
- Clinical Neuroscience Solutions, Inc
- Northwest Behavioral Research Center
- Capstone Clinical
- Baber Research Group, Inc
- Psychiatric Associates
- Louisiana Research Associates, Inc.
- Rochester Center For Behavioral Medicine
- Clinical Neurophysiology Services
- Psychiatric Care and Research Center
- Midwest Research Group
- Premier Psychiatric Research Institutute
- Center For Psychiatry and Behavioral Medicine, Inc
- Princeton Medical Institute
- Bioscience Research Llc
- Nyu Langone Medical Center
- Richard H Weisler, Md, Pa & Associates
- Midwest Clinical Research Center
- Ips Research Company
- Oregon Center For Clinical Investigations, Inc
- Oregon Center For Clinical Investigations
- Omega Medical Research
- Rainbow Research, Inc.
- Coastal Carolina Research
- Clinical Neuroscience Solutions
- Futuresearch Trials of Dallas, Lp
- Bayou City Research, Ltd
- Red Oak Psychiatry Associates
- Houston Clinical Trials, Llc
- Research Across America
- Neuroscience, Inc
- Eastside Therapeutic Resource
- Summit Research Network (Seattle) Llc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SHP465 12.5 mg
SHP465 37.5 mg
Placebo
Arm Description
Subjects will receive SHP465 12.5 mg
Subjects will receive SHP465 titrated up to 37.5 mg
Subjects will receive matching placebo
Outcomes
Primary Outcome Measures
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)
The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more severe symptoms.The scale is subdivided into 2 subscales of 9 symptoms each: hyperactivity/impulsivity and inattentiveness. Adult prompts are included with the ADHD-RS to create a semistructured measurement that allows the clinician to probe the extent, frequency, breadth, severity, and consequences of these symptoms to ascertain impairment in an adult population.
Secondary Outcome Measures
Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)
CGI scales permit a global evaluation of the participant's severity and improvement over time. CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02604407
Brief Title
Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
Official Title
A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 19, 2015 (Actual)
Primary Completion Date
March 24, 2016 (Actual)
Study Completion Date
March 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
Brief Summary
The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
275 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHP465 12.5 mg
Arm Type
Experimental
Arm Description
Subjects will receive SHP465 12.5 mg
Arm Title
SHP465 37.5 mg
Arm Type
Experimental
Arm Description
Subjects will receive SHP465 titrated up to 37.5 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive matching placebo
Intervention Type
Drug
Intervention Name(s)
SHP465 12.5mg capsules (one capsule daily)
Intervention Description
one capsule daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily)
Intervention Type
Drug
Intervention Name(s)
SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
Intervention Description
One capsule daily
Primary Outcome Measure Information:
Title
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)
Description
The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more severe symptoms.The scale is subdivided into 2 subscales of 9 symptoms each: hyperactivity/impulsivity and inattentiveness. Adult prompts are included with the ADHD-RS to create a semistructured measurement that allows the clinician to probe the extent, frequency, breadth, severity, and consequences of these symptoms to ascertain impairment in an adult population.
Time Frame
Baseline, Visit 6 (Week 4)
Secondary Outcome Measure Information:
Title
Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)
Description
CGI scales permit a global evaluation of the participant's severity and improvement over time. CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Time Frame
Visit 6 (Week 4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must be 18-55 years of age
Subject is able to provide written, personally signed and dated informed consent.
Subject is willing and able to comply with all of the testing and requirements defined in the protocol
Subject, who is a female, must not be pregnant.
Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities.
Subject has a primary diagnosis of ADHD.
Subject has an adult ADHD-RS with prompts total score ≥28 at the baseline visit.
Subject must have a minimum level of intellectual functioning, as determined by the investigator.
Subject is able to swallow a capsule.
Subject is currently not on ADHD therapy or is not completely satisfied with any aspect of their current ADHD therapy.
Exclusion Criteria:
Subject has a current, comorbid psychiatric diagnosis with significant symptoms.
Subject is considered a suicide risk in the opinion of the investigator
Subject has a body mass index (BMI) of <18.5 kg/m2 at the screening visit.
Subject has a BMI ≥40 kg/m2 at the screening visit.
Subject has a concurrent chronic or acute illness, disability, or other condition.
Subject has a history of seizure, a chronic or current tic disorder, or a current diagnosis of Tourette's disorder.
Subject has a history of moderate to severe hypertension.
Subject has a known history of symptomatic cardiovascular disease
Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
Subject has any clinically significant ECG or clinically significant laboratory abnormality at the screening visit.
Subject has current abnormal thyroid function
Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
Subject has failed to respond, to an adequate course(s) of amphetamine therapy.
Subject has a history of suspected substance abuse or dependence disorder.
Subject has a positive urine drug result at the screening visit (with the exception of subject's current stimulant therapy, if any) or Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the screening visit.
Subject has previously completed, has discontinued, or was withdrawn from this study.
Subject is taking any medication that is excluded or has not been appropriately washed out according to the protocol requirements.
Subject is required to take or anticipates the need to take medications that have CNS effects or affect performance.
Subject is female and is pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Pharmacology Research Institute (Pri)
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute (Pri)
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Nrc Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Elite Clinical Trials
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
Facility Name
McB Clinical Research
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Florida Clinical Research Center Llc
City
Bradenton
State/Province
Florida
ZIP/Postal Code
32401
Country
United States
Facility Name
Gulfcoast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Florida Clinical Research Center, Llc
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Qps Mra, Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Capstone Clinical
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Baber Research Group, Inc
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Louisiana Research Associates, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Rochester Center For Behavioral Medicine
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Clinical Neurophysiology Services
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
Psychiatric Care and Research Center
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Premier Psychiatric Research Institutute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Center For Psychiatry and Behavioral Medicine, Inc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Bioscience Research Llc
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Nyu Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Richard H Weisler, Md, Pa & Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Ips Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oregon Center For Clinical Investigations, Inc
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Oregon Center For Clinical Investigations
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Rainbow Research, Inc.
City
Barnwell
State/Province
South Carolina
ZIP/Postal Code
29812
Country
United States
Facility Name
Coastal Carolina Research
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Clinical Neuroscience Solutions
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Futuresearch Trials of Dallas, Lp
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Bayou City Research, Ltd
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
Red Oak Psychiatry Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Houston Clinical Trials, Llc
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Neuroscience, Inc
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Eastside Therapeutic Resource
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Summit Research Network (Seattle) Llc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28712074
Citation
Weisler RH, Greenbaum M, Arnold V, Yu M, Yan B, Jaffee M, Robertson B. Efficacy and Safety of SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults: Results of a Randomized, Double-Blind, Placebo-Controlled, Forced-Dose Clinical Study. CNS Drugs. 2017 Aug;31(8):685-697. doi: 10.1007/s40263-017-0455-7.
Results Reference
derived
Learn more about this trial
Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
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