7 completed, 1 terminated. 5 Phase 2, 2 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 5 |
| Phase 1 | 2 | Completed 2 |
| Phase 3 | 2 | Completed 1, Terminated 1 |
Follow Alcobra Ltd.: new trials by email
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| The MEASURE Study - A Phase 3 Study of MDX 1400 mg Daily Compared With Placebo in Adults With ADHD MDX, Placebo - Attention Deficit Hyperactivity Disorder (ADHD) | Phase 3 | Terminated | Alcobra Ltd. | 283 | 2015-06-01 | 2017-01-19 |
| Safety and Tolerability Study of Metadoxine Extended Release (MDX) (Previously Known as MG01CI) in PI-ADHD Adolescent Subjects Metadoxine extended release, Placebo - ADHD, Predominantly Inattentive Type | Phase 2 | Completed | Alcobra Ltd. | 83 | 2014-08-01 | 2015-03-04 |
| A 6-week, Study of MG01CI Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X Syndrome MG01CI extended-release tablet - Fragile X Syndrome | Phase 2 | Completed | Alcobra Ltd. | 62 | 2014-06-01 | 2016-07-06 |
| A 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hyperactivity ) MG01CI (1400 mg), placebo - ADHD, Attention-Deficit/Hyperactivity Disorder, Predominantly Inattentive Type | Phase 2 / Phase 3 | Completed | Alcobra Ltd. | 300 | 2014-03-01 | 2017-03-28 |
| Study Comparing Two Doses of MG01CI and Placebo in Adults With Predominantly Inattentive Attention Deficit Hyperactivity Disorder Metadoxine (MG01CI), Placebo - ADHD Predominantly Inattentive Type | Phase 2 | Completed | Alcobra Ltd. | 36 | 2013-08-01 | 2014-01-14 |
| A Phase 1 Study to Assess Pharmacokinetics of Metadoxine (MG01CI) 1400 mg, Administered to Healthy Volunteers Metadoxine (MG01CI ) - Healthy Adult Subjects | Phase 1 | Completed | Alcobra Ltd. | 16 | 2013-08-01 | 2014-01-14 |
| Clinical Efficacy & Safety, of Metadoxine (MG01CI) Extended Release in Attention-Deficit Hyperactivity Disorder (ADHD) Metadoxine (MG01CI) - ADHD | Phase 2 | Completed | Alcobra Ltd. | 120 | 2011-02-01 | 2012-04-20 |
| Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects Extended Release Metadoxine - Attention Deficit Hyperactivity Disorder | Phase 1 | Completed | Alcobra Ltd. | 43 | 2009-10-01 | 2017-03-13 |
Attention Deficit Disorder with Hyperactivity (6) · Fragile X Syndrome (1) · Syndrome (1)
metadoxine (5) · Sugars (1)
Israel (8) · United States (3)
Iris Manor, MD (3) · Elizabeth Berry-Kravis, MD, PhD (1) · Iris Manor, Dr. (1) · Jacob Atsmon, Dr. (1) · Jeffrey Newcorn, MD (1) · Richard Weisler, MD (1)