A 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hyperactivity )

NCT ID: NCT02059642

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-09-30

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.

Conditions

ADHD; Attention-Deficit/Hyperactivity Disorder, Predominantly Inattentive Type

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo 1400 mg administered orally once daily

MG01CI (1400 mg)

MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily

Group Type: EXPERIMENTAL

MG01CI (1400 mg)

Intervention Type: DRUG

MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily

Interventions

MG01CI (1400 mg)

MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily

Intervention Type: DRUG

placebo

Placebo 1400 mg administered orally once daily

Intervention Type: DRUG

Other Intervention Names

Metadoxine Immediate-release/Slow-release, Bilayer Caplet; Inactive Drug

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcobra Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Weisler, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Duke University

Locations

Sarkis Clinical Trials

Gainesville, Florida, United States

Miami Research

South Miami, Florida, United States

Capstone Clinical Research

Libertyville, Illinois, United States

Psychiatric Associates

Overland Park, Kansas, United States

University Kentucky Psychiatry

Lexington, Kentucky, United States

Pediatric Psychopharmacology & Adult ADHD Program, Massachusetts General Hospital

Boston, Massachusetts, United States

Rochester Center For Behavioral Medicine

Rochester Hills, Michigan, United States

Behavioral Medicine Center

Troy, Michigan, United States

St. Charles Psychiatric Associates

Saint Charles, Missouri, United States

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, United States

Bioscience Research

Mount Kisco, New York, United States

Duke University

Durham, North Carolina, United States

Richard H Weisler, MD, PA

Raleigh, North Carolina, United States

Sequoia Behavioral Healthcare

Media, Pennsylvania, United States

FutureResearch Trials

Austin, Texas, United States

FutureResearch Trials Dallas, LP

Dallas, Texas, United States

Bayou City Research

Houston, Texas, United States

NeuroScience, Inc. (NSI)

Herndon, Virginia, United States

Neurocognitive unit Rambam MC

Haifa, , Israel

ADHD unit Geha MC

Petah Tikva, , Israel

Countries

United States; Israel

Other Identifiers

AL012

Identifier Type: -

Identifier Source: org_study_id