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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in TOVA ADHD score from Screening/Baseline to 4 hours post-dose;
. Able to understand, read, write and speak Hebrew fluently to complete study related materials
Exclusion criteria
. Subjects with ADHD not otherwise specified (NOS) diagnosis
. 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