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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02477748
• Date of registration: 08/06/2015
• Prospective Registration: No
• Primary sponsor: Alcobra Ltd.
• Public title: The MEASURE Study - A Phase 3 Study of MDX 1400 mg Daily Compared With Placebo in Adults With ADHD
• Scientific 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)
• Date of first enrolment: June 2015
• Target sample size: 283
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02477748
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Israel, United States

Contacts

• Name: Jeffrey Newcorn, MD
• Affiliation: Icahn School of Medicine at Mount Sinai

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Attention Deficit Hyperactivity Disorder (ADHD)

Intervention(s)

Drug: Placebo

Drug: MDX

Primary Outcome(s)

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). [Time Frame: 10 weeks]

Secondary Outcome(s)

Adult ADHD Self Report Scale (ASRS-Self) v1.1 Symptom Checklist - expanded version [Time Frame: 10 weeks]

Questionnaires of Clinical Global Severity of Illness (CGI-S) and Clinical Global Improvement (CGI-I). [Time Frame: 10 weeks]

Safety as assessed by adverse events (AEs) [Time Frame: 10 weeks]

Safety as assessed by Columbia Suicide Severity Rating Scale (C-SSRS) [Time Frame: 10 weeks]

Safety as assessed by laboratory tests; blood and urine [Time Frame: 10 weeks]

Safety as assessed by supine blood pressure [Time Frame: 10 weeks]

Safety as assessed by heart rate measurements [Time Frame: 10 weeks]

Safety as assessed by physical examinations [Time Frame: 10 weeks]

Safety as assessed by discontinuations due to AEs [Time Frame: 10 weeks]

Safety as assessed by Electrocardiogram (ECG) test [Time Frame: 10 weeks]

Safety as assessed by neurological evaluation [Time Frame: 10 weeks]

Safety as assessed by respiratory rate measurements [Time Frame: 10 weeks]

Safety as assessed by body temperature measurements [Time Frame: 10 weeks]

Test of Variables of Attention (TOVA) [Time Frame: 10 weeks]

Secondary ID(s)

AL016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors