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

NCT02059642 | Completed Phase 2 Results

• 1 other identifier: AL012
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 20

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 6 weeks

Secondary Outcomes (1)

• Safety Evaluation of Treatment on the Basis of Percentage of Participants With Treatment Emergent Adverse Events

  6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

MG01CI (1400 mg)

EXPERIMENTAL

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

Drug: MG01CI (1400 mg)

Interventions

MG01CI (1400 mg) DRUG

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

Also known as: Metadoxine Immediate-release/Slow-release, Bilayer Caplet

MG01CI (1400 mg)

placebo DRUG

Placebo 1400 mg administered orally once daily

Also known as: Inactive Drug

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcobra Ltd.: lead

Study Sites (20)

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Miami Research

South Miami, Florida, 33173, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

University Kentucky Psychiatry

Lexington, Kentucky, 40509, United States

Location

Pediatric Psychopharmacology & Adult ADHD Program, Massachusetts General Hospital

Boston, Massachusetts, 21144, United States

Location

Rochester Center For Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Behavioral Medicine Center

Troy, Michigan, 48083, United States

Location

St. Charles Psychiatric Associates

Saint Charles, Missouri, 63301, United States

Location

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Bioscience Research

Mount Kisco, New York, 10549, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Richard H Weisler, MD, PA

Raleigh, North Carolina, 27609, United States

Location

Sequoia Behavioral Healthcare

Media, Pennsylvania, 19063, United States

Location

FutureResearch Trials

Austin, Texas, 78731, United States

Location

FutureResearch Trials Dallas, LP

Dallas, Texas, 75231, United States

Location

Bayou City Research

Houston, Texas, 77007, United States

Location

NeuroScience, Inc. (NSI)

Herndon, Virginia, 20170, United States

Location

Neurocognitive unit Rambam MC

Haifa, Israel

Location

ADHD unit Geha MC

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jonathan Rubin
• Organization: Alcobra

jrubin@alcobra-pharma.com

610-940-1631

Study Officials

• Richard Weisler, MD

  University of North Carolina, Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 11, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 28, 2017
• Results First Posted: March 28, 2017

Record last verified: 2014-03

Locations

IL (2); US (18)