The MEASURE Study - A Phase 3 Study of MDX 1400 mg Daily Compared With Placebo in Adults With ADHD

NCT02477748 | Terminated Phase 3 DMC

• 1 other identifier: AL016
• Study Type: interventional
• Target: 283
• Locations: 2 countries
• Sites: 38

Brief Summary

This study is a multi-center, randomized, double-blind, placebo-controlled, phase 3 study of MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD. The study will be comprised of Screening, Washout (if required), Treatment (total of 10 weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial eligibility assessments.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• 18-item total ADHD symptom score of the Conners Adult ADHD Rating Scale:O-SV (with the investigator as observer) with adult ADHD prompts (CAARS investigator).

  The scale will be analyzed by change from Baseline to Week 10.

  10 weeks

Secondary Outcomes (19)

• Questionnaires of Clinical Global Severity of Illness (CGI-S) and Clinical Global Improvement (CGI-I).

  10 weeks

• Adult ADHD Self Report Scale (ASRS-Self) v1.1 Symptom Checklist - expanded version

  10 weeks

• Test of Variables of Attention (TOVA)

  10 weeks

• Test of Variables of Attention (TOVA)

  10 weeks

• Test of Variables of Attention (TOVA)

  10 weeks

Study Arms (2)

MDX

ACTIVE COMPARATOR

Metadoxine Immediate-release/slow-release, bilayer tablet PO of 1400 mg, taken once daily for 10 weeks.; alternative name: MG01CI.

Drug: MDX

Placebo

PLACEBO COMPARATOR

Inert tablets

Drug: Placebo

Interventions

MDX DRUG

Immediate-release/slow-release,bilayer tablet PO of 1400 mg, taken once daily for 10 weeks.

Also known as: MG01CI

MDX

Placebo DRUG

Tablet PO, taken once daily for 10 weeks.

Also known as: Inert tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• 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, Fifth Edition (DSM5) as assessed by the Adult ADHD Clinician Diagnostic Scale, (ACDS Version 1.2) modified for DSM-IV and DSM5 diagnoses; a diagnosis of ADHD not otherwise specified is unacceptable.
• Male and 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 the local language fluently to complete the study-related materials.
• Subject is able to understand and sign an informed consent form to participate in the study.

You may not qualify if:

• Subject has any current major psychiatric condition (e.g., schizophrenia, bipolar or personality disorder) or autism spectrum disorder.
• Subject has any clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation.
• Subject has used an investigational medication/treatment or was enrolled in another clinical trial in the 30 days before the Screening visit.
• Subject has used any medication or food supplement that the investigator or the medical monitor consider unacceptable during the 14-day period before the Baseline visit.
• Subject's alcohol and caffeine intake will be assessed.
• Subject has current suicidality, defined as active ideation, intent or plan, or any significant lifetime suicidal behavior (actual attempt, aborted attempt, interrupted attempt, or act or preparation towards imminently making a suicide attempt). Subjects exhibiting history (within previous 12 months) of non-suicidal self-injurious behavior will be excluded.
• Subject has taken any prescription or non-prescription medication for ADHD during the 14 days (or 21 days for atomoxetine) before the Baseline visit. Subjects will not be allowed to take any other medications for ADHD besides the study medication (when prescribed) after the washout period and for the duration of the study, up to and including the safety Follow-up visit. (Other ADHD medications should NOT be prescribed to subjects before completion of the Follow-up visit or Early Termination Visit).
• Subject is significantly visually impaired to an extent that is not able to be corrected by prescription glasses or contact lenses.
• Subject is closely related to the sponsor, investigator, or study staff. Eligibility of subjects with any relationship to the sponsor, investigator, or study staff will be discussed with the medical monitor before study entry, and the medical monitor will decide on the eligibility of these cases.
• Subject has previously been enrolled in an MDX clinical trial.
• Subject lives in the same household as another subject in this clinical trial or in another on-going trial with MDX. Subject lives in the same household as someone who has previously participated in a trial with MDX.
• 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, including (but not limited to) abnormally low intellectual capacity as judged by the investigator.
• 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. Complete entry criteria will be reviewed and evaluated individually by a protocol trained delegate.

Sponsors & Collaborators

• Alcobra Ltd.: lead

Study Sites (38)

Harmonex, Inc.

Dothan, Alabama, 36303, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MCB Clinical Research Centers

Colorado Springs, Colorado, 80910, United States

Location

Connecticut Clinical Research

Cromwell, Connecticut, 06416, United States

Location

Coastal Connecticut Research

New London, Connecticut, 06320, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Clinical Neuroscience Solutions

Jacksonville, Florida, 32256, United States

Location

CNS Healthcare

Orlando, Florida, 32801, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Institute for Advanced Medical Research

Alpharetta, Georgia, 30005, United States

Location

Goldpoint Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Rochester Center For Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Premier Psychiatric Research Institute

Lincoln, Nebraska, 68526, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Global Medical Institutes, LLC, Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

The Medical Research Network

New York, New York, 10128, United States

Location

Richard H Weisler, MD, PA

Raleigh, North Carolina, 27609, United States

Location

Neuro-Behavioral Clinical Research, Inc.

Canton, Ohio, 44718, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Village Clinical Research Inc

Oklahoma City, Oklahoma, 73103, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Carolina Clinical Research, Inc.

Charleston, South Carolina, 29405, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

BioBehavioral Research of Austin at Specialty Clinic of Austin

Austin, Texas, 78759, United States

Location

Bayou City Research

Houston, Texas, 77007, United States

Location

Psychiatric & Behavioral Solutions

Salt Lake City, Utah, 84105, United States

Location

NeuroScience, Inc. (NSI)

Herndon, Virginia, 20170, United States

Location

Summit Research Network(Seattle)LLC

Seattle, Washington, 98104, United States

Location

Dean Foundation - Middleton

Middleton, Wisconsin, 53562, United States

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Geha Medical Centre

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

Study Officials

• Jeffrey Newcorn, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 19, 2017

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2); US (36)