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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder (ADHD)

In brief

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.

Key facts

Study ID: NCT02477748
Run by: Alcobra Ltd.
People needed: 283
Starts: 2015-06-01
Expected to finish: 2017-01-01
Last updated by the study team: 2017-01-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

Harmonex, Inc. — Dothan, Alabama, United States
Pharmacology Research Institute — Los Alamitos, California, United States
Pharmacology Research Institute — Newport Beach, California, United States
Artemis Institute for Clinical Research — San Diego, California, United States
University of California, San Francisco — San Francisco, California, United States
MCB Clinical Research Centers — Colorado Springs, Colorado, United States
Connecticut Clinical Research — Cromwell, Connecticut, United States
Coastal Connecticut Research — New London, Connecticut, United States
Sarkis Clinical Trials — Gainesville, Florida, United States
Clinical Neuroscience Solutions — Jacksonville, Florida, United States
CNS Healthcare — Orlando, Florida, United States
Miami Research Associates — South Miami, Florida, United States
Institute for Advanced Medical Research — Alpharetta, Georgia, United States
Goldpoint Clinical Research — Indianapolis, Indiana, United States
Lake Charles Clinical Trials — Lake Charles, Louisiana, United States
Kennedy Krieger Institute — Baltimore, Maryland, United States
Rochester Center For Behavioral Medicine — Rochester Hills, Michigan, United States
St. Charles Psychiatric Associates - Midwest Research Group — Saint Charles, Missouri, United States
Premier Psychiatric Research Institute — Lincoln, Nebraska, United States
Center for Emotional Fitness — Cherry Hill, New Jersey, United States
Global Medical Institutes, LLC, Princeton Medical Institute — Princeton, New Jersey, United States
The Medical Research Network — New York, New York, United States
Richard H Weisler, MD, PA — Raleigh, North Carolina, United States
Neuro-Behavioral Clinical Research, Inc. — Canton, Ohio, United States
IPS Research Company — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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