A 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hy… (NCT02059642) | Clinical Trial Compass
CompletedPhase 2/3
A 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hyperactivity )
United States300 participantsStarted 2014-03
Plain-language summary
This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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, Fourth Edition (DSM-IV) and DSM5.
* Subject has ADHD with at least moderate clinical severity (Clinical Global Impression-Severity \[CGI-S\]) score of 4 or greater).
* Subject has a score on the total ADHD symptom score with adult prompts of the CAARS-Inv of at least 22.
* 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 English fluently to complete the study-related materials (or Hebrew for Israeli subjects).
* Subject is able to understand and sign an informed consent form to participate in the study.
Exclusion Criteria:
* Subject did not respond in the past to 2 adequate trials of stimulant treatments or 1 adequate trial of atomoxetine treatment (in the investigator's judgment).
* Subject has any psychiatric condition clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by the investigator .
* Subject has a known or suspected human immune deficiency virus-positive status or has diseases such as acquired immunodeficiency…
What they're measuring
1
Change in Total ADHD Symptom Score With Adult Prompts of the Conners Adult ADHD Rating Scale:O-SV in ADHD Adults From Baseline to 6 Weeks