The MEASURE Study - A Phase 3 Study of MDX 1400 mg Daily Compared With Placebo in Adults With ADHD
NCT ID: NCT02477748
Last Updated: 2017-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
283 participants
INTERVENTIONAL
2015-06-30
2017-01-31
Brief Summary
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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.
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Detailed Description
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* 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.
* Subjects requiring a washout will undergo a Washout period where ADHD medication is discontinued (21 days for atomoxetine, 14 days for other ADHD medications). These subjects will have an Interim Visit (off drug) on or about Day -10 (Day -10 to Day -3) for CAARS-Inv assessment at the end of the Washout period.
* Subjects will be randomly assigned to placebo/MDX for a total treatment duration of up to ten weeks.
There will be a one week Follow-up period after the last dose of study treatment or early termination.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MDX
Metadoxine Immediate-release/slow-release, bilayer tablet PO of 1400 mg, taken once daily for 10 weeks.; alternative name: MG01CI.
MDX
Immediate-release/slow-release,bilayer tablet PO of 1400 mg, taken once daily for 10 weeks.
Placebo
Inert tablets
Placebo
Tablet PO, taken once daily for 10 weeks.
Interventions
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MDX
Immediate-release/slow-release,bilayer tablet PO of 1400 mg, taken once daily for 10 weeks.
Placebo
Tablet PO, taken once daily for 10 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Male and Female subjects of childbearing potential must agree to use an effective contraceptive throughout the study
4. Subject is able to attend the clinic regularly and reliably.
5. Subject is able to swallow tablets and capsules.
6. Subject is able to understand, read, write, and speak the local language fluently to complete the study-related materials.
7. Subject is able to understand and sign an informed consent form to participate in the study.
Exclusion Criteria
2. Subject has any clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation.
3. Subject has used an investigational medication/treatment or was enrolled in another clinical trial in the 30 days before the Screening visit.
4. 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.
5. Subject's alcohol and caffeine intake will be assessed.
6. 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.
7. 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).
8. Subject is significantly visually impaired to an extent that is not able to be corrected by prescription glasses or contact lenses.
9. 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.
10. Subject has previously been enrolled in an MDX clinical trial.
11. 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.
12. 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.
13. 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.
14. Subject is pregnant, lactating, or using an inadequate contraceptive method. Complete entry criteria will be reviewed and evaluated individually by a protocol trained delegate.
18 Years
55 Years
ALL
Yes
Sponsors
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Alcobra Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Newcorn, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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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
Village Clinical Research Inc
Oklahoma City, Oklahoma, United States
Summit Research Network
Portland, Oregon, United States
Suburban Research Associates
Media, Pennsylvania, United States
Carolina Clinical Research, Inc.
Charleston, South Carolina, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, United States
BioBehavioral Research of Austin at Specialty Clinic of Austin
Austin, Texas, United States
Bayou City Research
Houston, Texas, United States
Psychiatric & Behavioral Solutions
Salt Lake City, Utah, United States
NeuroScience, Inc. (NSI)
Herndon, Virginia, United States
Summit Research Network(Seattle)LLC
Seattle, Washington, United States
Dean Foundation - Middleton
Middleton, Wisconsin, United States
Rambam Medical Center
Haifa, , Israel
Geha Medical Centre
Petah Tikva, , Israel
Countries
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Other Identifiers
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AL016
Identifier Type: -
Identifier Source: org_study_id
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