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

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

A 10-week Randomized, Multicenter, Double-blind, Parallel, Fixed-dose Study of MDX (Metadoxine Immediate-release/Slow-release, Bilayer Tablet) 1400 mg Compared With Placebo in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02477748
• Other study ID #: AL016
• Status: Terminated
• Phase: Phase 3
• First received: June 8, 2015
• Last updated: January 18, 2017
• Start date: June 2015
• Est. completion date: January 2017

Study information

• Verified date: April 2016
• Source: Alcobra Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

• A 10-week randomized, multi-center, 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.

• 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 283
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Subject is a man or a non-pregnant, non-lactating woman 18 to 55 years of age, inclusive, at the Screening visit.

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

1. Subject has any current major psychiatric condition (e.g., schizophrenia, bipolar or personality disorder) or autism spectrum disorder.

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	Geha Medical Centre	Petah Tiqva
United States	Institute for Advanced Medical Research	Alpharetta	Georgia
United States	BioBehavioral Research of Austin at Specialty Clinic of Austin	Austin	Texas
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	Neuro-Behavioral Clinical Research, Inc.	Canton	Ohio
United States	Carolina Clinical Research, Inc.	Charleston	South Carolina
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	MCB Clinical Research Centers	Colorado Springs	Colorado
United States	Connecticut Clinical Research	Cromwell	Connecticut
United States	Harmonex, Inc.	Dothan	Alabama
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	NeuroScience, Inc. (NSI)	Herndon	Virginia
United States	Bayou City Research	Houston	Texas
United States	Goldpoint Clinical Research	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions	Jacksonville	Florida
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Premier Psychiatric Research Institute	Lincoln	Nebraska
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Suburban Research Associates	Media	Pennsylvania
United States	Clinical Neuroscience Solutions	Memphis	Tennessee
United States	Dean Foundation - Middleton	Middleton	Wisconsin
United States	Coastal Connecticut Research	New London	Connecticut
United States	The Medical Research Network	New York	New York
United States	Pharmacology Research Institute	Newport Beach	California
United States	Village Clinical Research Inc	Oklahoma	Oklahoma
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	CNS Healthcare	Orlando	Florida
United States	Summit Research Network	Portland	Oregon
United States	Global Medical Institutes, LLC, Princeton Medical Institute	Princeton	New Jersey
United States	Richard H Weisler, MD, PA	Raleigh	North Carolina
United States	Rochester Center For Behavioral Medicine	Rochester Hills	Michigan
United States	Psychiatric & Behavioral Solutions	Salt Lake City	Utah
United States	Artemis Institute for Clinical Research	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	Summit Research Network(Seattle)LLC	Seattle	Washington
United States	Miami Research Associates	South Miami	Florida
United States	St. Charles Psychiatric Associates - Midwest Research Group	St. Charles	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Alcobra Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Questionnaires of Clinical Global Severity of Illness (CGI-S) and Clinical Global Improvement (CGI-I).	The questionnaires will be analyzed by change from Baseline to all visits as well as by response rates.	10 weeks
Secondary	Adult ADHD Self Report Scale (ASRS-Self) v1.1 Symptom Checklist - expanded version	The scale will be analyzed by change from Baseline to Week 10 in total score and sub- scales.	10 weeks
Secondary	Test of Variables of Attention (TOVA)	A continuous performance test performed on the computer. Change from Baseline and response rate of Attention Comparison Score (ACS) will be assessed.	10 weeks
Secondary	Test of Variables of Attention (TOVA)	A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in variability of response time will be assessed.	10 weeks
Secondary	Test of Variables of Attention (TOVA)	A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in response time will be assessed.	10 weeks
Secondary	Test of Variables of Attention (TOVA)	A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in errors of commission will be assessed.	10 weeks
Secondary	Test of Variables of Attention (TOVA)	A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in errors of omission will be assessed.	10 weeks
Secondary	Test of Variables of Attention (TOVA)	A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in D-prime will be assessed.	10 weeks
Secondary	Safety as assessed by adverse events (AEs)	Any undesirable experience associated with the use of a medical product in a subject	10 weeks
Secondary	Safety as assessed by body temperature measurements	Body temperature measurements as part of vital signs measurements	10 weeks
Secondary	Safety as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)	C-SSRS scale allows investigators to gather lifetime history of suicidality as well as any recent suicidal ideation and/or behavior	10 weeks
Secondary	Safety as assessed by laboratory tests; blood and urine	Laboratory test results (hematology, chemistry and urinalysis).	10 weeks
Secondary	Safety as assessed by neurological evaluation	Neurological evaluation done by investigator	10 weeks
Secondary	Safety as assessed by Electrocardiogram (ECG) test	Analysis and Interpretation of the Electrocardiogram	10 weeks
Secondary	Safety as assessed by physical examinations	Physical examination done by investigator	10 weeks
Secondary	Safety as assessed by discontinuations due to AEs	Discontinuations of subjects due to AEs	10 weeks
Secondary	Safety as assessed by heart rate measurements	Heart rate measurements as part of vital signs measurements	10 weeks
Secondary	Safety as assessed by respiratory rate measurements	Respiratory rate measurements as part of vital signs measurements	10 weeks
Secondary	Safety as assessed by supine blood pressure	Supine blood pressure as part of vital signs measurements	10 weeks