A 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hyperactivity )
Primary Purpose
ADHD, Attention-Deficit/Hyperactivity Disorder, Predominantly Inattentive Type
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MG01CI (1400 mg)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for ADHD
Eligibility Criteria
Inclusion Criteria:
- Subject is a man or a non-pregnant, non-lactating woman 18 to 55 years of age, inclusive, at the Screening Visit.
- Subject has a diagnosis of ADHD based on criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and DSM5.
- Subject has ADHD with at least moderate clinical severity (Clinical Global Impression-Severity [CGI-S]) score of 4 or greater).
- Subject has a score on the total ADHD symptom score with adult prompts of the CAARS-Inv of at least 22.
- Female subjects of childbearing potential must agree to use an effective contraceptive throughout the study
- Subject is able to attend the clinic regularly and reliably.
- Subject is able to swallow tablets and capsules.
- Subject is able to understand, read, write, and speak English fluently to complete the study-related materials (or Hebrew for Israeli subjects).
- Subject is able to understand and sign an informed consent form to participate in the study.
Exclusion Criteria:
- Subject did not respond in the past to 2 adequate trials of stimulant treatments or 1 adequate trial of atomoxetine treatment (in the investigator's judgment).
- Subject has any psychiatric condition clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by the investigator .
- Subject has a known or suspected human immune deficiency virus-positive status or has diseases such as acquired immunodeficiency disorder, hepatitis C, hepatitis B, or tuberculosis.
- Subject has a history of an allergy or sensitivity to B-complex vitamins.
- Subject has a history of intellectual disability or a history or suspicion of autism spectrum disorder.
- Subject has a current Axis I diagnosis (other than ADHD) according to the Structured Clinical Interview for DSM IV Axis I Disorders (SCID) or has a lifetime history of bipolar disorder or psychosis.
- Subject has used mega-dose vitamin B6/pyridoxine during the 28 days before the Screening Visit.
- Subject has used high-dose supplements of omega-3 fatty acids ≥ 500 mg on at least 1 day or folic acid supplements during the 2 weeks before the Screening Visit.
- Subject has used an investigational medication/treatment in the 30 days before the Screening Visit
- Subject has used any medication or food supplement that the investigator or the medical monitor considers unacceptable during the 14-day period before randomization.
- Subject has a current drug or alcohol dependence or substance abuse disorder according to DSM-IV. Subject should also agree to keep their caffeine intake consistent and refrain from consuming ≥300 mg per day of caffeine (no more than three 8-ounce servings of coffee) during the study.
- Subject has suicidality, defined as active ideation, an intent or plan, or any significant lifetime suicidal behavior. Subjects exhibiting history (within previous 12 months) of non-suicidal self-injurious behavior will be excluded.
- Subject has taken any prescription or non-prescription ADHD medications during the 14 days (for all psychotropic medications other than fluoxetine) or 28 days (for fluoxetine) before the randomization visit.
- Subject is significantly visually impaired to an extent that is not able to be corrected by prescription glasses or contact lenses
- Subject is related to the sponsor, investigator, or study staff.
- Subject has any condition that, in the principal investigator's opinion, would place the subject at risk or influence the conduct of the study or interpretation of results,
- Subject cannot fully comprehend the implications of the protocol, cannot comply with its requirements, or is incapable of following the study schedule for any reason.
- Subject is pregnant, lactating, or using an inadequate contraceptive method.
- If there is a ≥25% change in the CAARS-Inv results between the Interim visit (off drug) assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. For subjects not needing washout, if there is a ≥25% change in the CAARS-Inv results between the Screening Visit assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized.
Sites / Locations
- Sarkis Clinical Trials
- Miami Research
- Capstone Clinical Research
- Psychiatric Associates
- University Kentucky Psychiatry
- Pediatric Psychopharmacology & Adult ADHD Program, Massachusetts General Hospital
- Rochester Center For Behavioral Medicine
- Behavioral Medicine Center
- St. Charles Psychiatric Associates
- Center for Psychiatry and Behavioral Medicine
- Bioscience Research
- Duke University
- Richard H Weisler, MD, PA
- Sequoia Behavioral Healthcare
- FutureResearch Trials
- FutureResearch Trials Dallas, LP
- Bayou City Research
- NeuroScience, Inc. (NSI)
- Neurocognitive unit Rambam MC
- ADHD unit Geha MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
MG01CI (1400 mg)
Arm Description
Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily
MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily
Outcomes
Primary Outcome Measures
Change in Total ADHD Symptom Score With Adult Prompts of the Conners Adult ADHD Rating Scale:O-SV in ADHD Adults From Baseline to 6 Weeks
Primary efficacy endpoint: change from Baseline in the total ADHD symptom score with adult prompts of the CAARS-Inv. The CAARS is a scale to assess the presence and severity of ADHD symptoms and behaviors in adults. During an interview with the investigator, subject rates items pertaining to their behavior using a 4-point Likert-style format ranging from 0 ('Not at all') to 3 ('Very much). The scale measures ADHD symptoms across clinically significant domains using a 30 item questionnaire, while examining the manifestations of those symptoms. The scale includes an assessment of 9 inattentive symptoms (Subset A) and 9 hyperactive & impulsive symptoms (Subset B). The total ADHD symptom score, Subset C (the sum of the inattentive symptom scores from Subset A and the hyperactive & impulsive symptoms from Subset B) is the primary outcome measure. Scores of the scale for Subset C, comprised of scores from 18 questions,range from 0 (no ADHD symptoms) to 54, highest rating of ADHD symptoms.
Secondary Outcome Measures
Safety Evaluation of Treatment on the Basis of Percentage of Participants With Treatment Emergent Adverse Events
Safety assessments will be based on changes from Baseline of clinical AEs reported by the subject or observed by the Investigator and concomitant medication use, treatment adherence (eg, dropouts due to AEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02059642
Brief Title
A 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hyperactivity )
Official Title
A 6-week Randomized, Multicenter, Double-blind, Parallel, Fixed-dose Study of MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg Compared With Placebo in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcobra Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD.
Detailed Description
This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg once daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD. The study comprises a Screening Visit at which initial assessment will be made and then a Washout Period during which prospective subjects must discontinue ADHD medication for 14 days (for psychotropic medications other than fluoxetine) or for 28 days (for fluoxetine) before randomization into the study. The Washout Period is 14 days, but may be extended to 28 days for a fluoxetine washout. Subjects requiring either a 14-day or a 28-day Washout Period will have an Interim Visit (off drug) on or about Day -8 (Day -10 to Day -3) for CAARS-Inv assessment after the Washout Period. The Baseline CAARS Inv assessment will be conducted on Day 0. If there is a ≥25% change in the CAARS-Inv results between the Interim Visit (off drug) assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. For subjects not needing washout, if there is a ≥25% change in the CAARS-Inv results between the Screening Visit assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. Following the Washout Period for those requiring a washout, or following the Screening Visit for those subjects who do not require a washout, eligible subjects will undergo baseline assessments and be randomized on Day 0 to MG01CI 1400 mg or to matching placebo and begin the Double-blind Treatment Period. The Double-blind Treatment Period will be 6 weeks in duration. There will be a 2-week Follow-up Period after the last dose of study treatment or early termination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Attention-Deficit/Hyperactivity Disorder, Predominantly Inattentive Type
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily
Arm Title
MG01CI (1400 mg)
Arm Type
Experimental
Arm Description
MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily
Intervention Type
Drug
Intervention Name(s)
MG01CI (1400 mg)
Other Intervention Name(s)
Metadoxine Immediate-release/Slow-release, Bilayer Caplet
Intervention Description
MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Inactive Drug
Intervention Description
Placebo 1400 mg administered orally once daily
Primary Outcome Measure Information:
Title
Change in Total ADHD Symptom Score With Adult Prompts of the Conners Adult ADHD Rating Scale:O-SV in ADHD Adults From Baseline to 6 Weeks
Description
Primary efficacy endpoint: change from Baseline in the total ADHD symptom score with adult prompts of the CAARS-Inv. The CAARS is a scale to assess the presence and severity of ADHD symptoms and behaviors in adults. During an interview with the investigator, subject rates items pertaining to their behavior using a 4-point Likert-style format ranging from 0 ('Not at all') to 3 ('Very much). The scale measures ADHD symptoms across clinically significant domains using a 30 item questionnaire, while examining the manifestations of those symptoms. The scale includes an assessment of 9 inattentive symptoms (Subset A) and 9 hyperactive & impulsive symptoms (Subset B). The total ADHD symptom score, Subset C (the sum of the inattentive symptom scores from Subset A and the hyperactive & impulsive symptoms from Subset B) is the primary outcome measure. Scores of the scale for Subset C, comprised of scores from 18 questions,range from 0 (no ADHD symptoms) to 54, highest rating of ADHD symptoms.
Time Frame
baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Safety Evaluation of Treatment on the Basis of Percentage of Participants With Treatment Emergent Adverse Events
Description
Safety assessments will be based on changes from Baseline of clinical AEs reported by the subject or observed by the Investigator and concomitant medication use, treatment adherence (eg, dropouts due to AEs)
Time Frame
6 weeks
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 is a man or a non-pregnant, non-lactating woman 18 to 55 years of age, inclusive, at the Screening Visit.
Subject has a diagnosis of ADHD based on criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and DSM5.
Subject has ADHD with at least moderate clinical severity (Clinical Global Impression-Severity [CGI-S]) score of 4 or greater).
Subject has a score on the total ADHD symptom score with adult prompts of the CAARS-Inv of at least 22.
Female subjects of childbearing potential must agree to use an effective contraceptive throughout the study
Subject is able to attend the clinic regularly and reliably.
Subject is able to swallow tablets and capsules.
Subject is able to understand, read, write, and speak English fluently to complete the study-related materials (or Hebrew for Israeli subjects).
Subject is able to understand and sign an informed consent form to participate in the study.
Exclusion Criteria:
Subject did not respond in the past to 2 adequate trials of stimulant treatments or 1 adequate trial of atomoxetine treatment (in the investigator's judgment).
Subject has any psychiatric condition clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by the investigator .
Subject has a known or suspected human immune deficiency virus-positive status or has diseases such as acquired immunodeficiency disorder, hepatitis C, hepatitis B, or tuberculosis.
Subject has a history of an allergy or sensitivity to B-complex vitamins.
Subject has a history of intellectual disability or a history or suspicion of autism spectrum disorder.
Subject has a current Axis I diagnosis (other than ADHD) according to the Structured Clinical Interview for DSM IV Axis I Disorders (SCID) or has a lifetime history of bipolar disorder or psychosis.
Subject has used mega-dose vitamin B6/pyridoxine during the 28 days before the Screening Visit.
Subject has used high-dose supplements of omega-3 fatty acids ≥ 500 mg on at least 1 day or folic acid supplements during the 2 weeks before the Screening Visit.
Subject has used an investigational medication/treatment in the 30 days before the Screening Visit
Subject has used any medication or food supplement that the investigator or the medical monitor considers unacceptable during the 14-day period before randomization.
Subject has a current drug or alcohol dependence or substance abuse disorder according to DSM-IV. Subject should also agree to keep their caffeine intake consistent and refrain from consuming ≥300 mg per day of caffeine (no more than three 8-ounce servings of coffee) during the study.
Subject has suicidality, defined as active ideation, an intent or plan, or any significant lifetime suicidal behavior. Subjects exhibiting history (within previous 12 months) of non-suicidal self-injurious behavior will be excluded.
Subject has taken any prescription or non-prescription ADHD medications during the 14 days (for all psychotropic medications other than fluoxetine) or 28 days (for fluoxetine) before the randomization visit.
Subject is significantly visually impaired to an extent that is not able to be corrected by prescription glasses or contact lenses
Subject is related to the sponsor, investigator, or study staff.
Subject has any condition that, in the principal investigator's opinion, would place the subject at risk or influence the conduct of the study or interpretation of results,
Subject cannot fully comprehend the implications of the protocol, cannot comply with its requirements, or is incapable of following the study schedule for any reason.
Subject is pregnant, lactating, or using an inadequate contraceptive method.
If there is a ≥25% change in the CAARS-Inv results between the Interim visit (off drug) assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. For subjects not needing washout, if there is a ≥25% change in the CAARS-Inv results between the Screening Visit assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Weisler, MD
Organizational Affiliation
University of North Carolina, Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Miami Research
City
South Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
University Kentucky Psychiatry
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Pediatric Psychopharmacology & Adult ADHD Program, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
21144
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
Behavioral Medicine Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48083
Country
United States
Facility Name
St. Charles Psychiatric Associates
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Bioscience Research
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Richard H Weisler, MD, PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Sequoia Behavioral Healthcare
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
FutureResearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
FutureResearch Trials Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Bayou City Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
NeuroScience, Inc. (NSI)
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Neurocognitive unit Rambam MC
City
Haifa
Country
Israel
Facility Name
ADHD unit Geha MC
City
Petach Tikva
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hyperactivity )
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