Study Comparing Two Doses of MG01CI and Placebo in Adults With Predominantly Inattentive Attentio… (NCT01685281) | Clinical Trial Compass
CompletedPhase 2
Study Comparing Two Doses of MG01CI and Placebo in Adults With Predominantly Inattentive Attention Deficit Hyperactivity Disorder
Israel36 participantsStarted 2013-08
Plain-language summary
study objectives are to compare the efficacy, safety and tolerability of two doses of MG01CI (1400 mg and 700 mg) to Placebo for the treatment of symptoms in adults diagnosed with PI-ADHD.
subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as follows:
1. week 1:1400 mg, week 2:700 mg, week 3:placebo
2. week 1:700 mg,week 2: placebo,week 3:1400 mg
3. week 1: placebo, week2:1400 mg, week 3 700 mg
The study will consist of three periods: a screening period of up to one week, a 3-week double-blind treatment period, and a one-week safety follow-up period.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Adult men and women, 18 to 55 years old
✓. Diagnosed with predominantly inattentive ADHD based on DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS V1.2);
✓. Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above)
✓. TOVA ADHD score of -1.8 or below at Screening /Baseline
✓. Women with childbearing potential must agree to use effective contraceptive and have negative urine pregnancy test at screening visit
✓. Able to attend the clinic regularly and reliably
✓. Able to swallow tablets/capsules
✓. Able to understand, read, write and speak Hebrew fluently to complete study related materials
Exclusion criteria
✕. Subjects with ADHD not otherwise specified (NOS) diagnosis
What they're measuring
1
Change in TOVA ADHD score from Screening/Baseline to 4 hours post-dose;
. Subjects with combined type or predominantly hyperactive impulsive ADHD diagnoses
✕. Subjects with current Axis I diagnosis on SCID
✕. Subjects with lifetime bipolar or psychosis
✕. Subjects in treatment for Axis I disorders, even if the disorder is remitted
✕. Subjects who were non-responders to at least two adequately administered ADHD treatments
✕. Subjects with any medical or psychiatric condition common diseases such as hypertension, type 2 diabetes mellitus, hyperlipidemia, etc. are allowed per the Investigator's judgment, as long as they are stable and controlled by medical therapy that is constant for at least 8 weeks prior to randomization and throughout the study
✕. Any prescription or non-prescription ADHD medications during the 14 days (for stimulants) or 28 days (for non-stimulants and other psychotropics) prior to the screening visit