Drugs / Metadoxine
Metadoxine
also known as
MG01CI · MDX · Metadoxine (pyridoxol L-2-pyrrolidone-5-carboxylate) · MG01CI ,metadoxine · MTD · MTDX
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01933997 | Aug → Oct 2013 | — | Alcobra Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00995085 | Oct 2009 → Oct 2010 | attention deficit-hyperactivity disorder | Alcobra Ltd. | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT02189772 | Aug 2014 → Jan 2015 | attention deficit hyperactivity disorder, inattentive type | Alcobra Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02126995 | Jun 2014 → Jun 2015 | fragile X syndrome | Alcobra Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01504295 | Apr 2012 → Jan 2015 | alcohol dependence, alcoholic liver disease | Brown University | Completed | No outcome recorded |
| Phase 2 | NCT01243242 | Feb → Aug 2011 | attention deficit-hyperactivity disorder | Alcobra Ltd. | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT02541045 | Aug 2015 → Mar 2024 | metabolic dysfunction-associated steatohepatitis | Hospital General de Mexico | Withdrawn | No outcome recorded Stop: Business |
| Phase 42 trials · 1 met primary | ||||||
| Phase 4 | NCT02051842 | Jan 2016 → Jan 2020 | fatty liver disease, prediabetes syndrome | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Unknown | No outcome recorded |
| Phase 4 | NCT02161653 | Apr 2010 → Sep 2014 | alcoholic hepatitis | Hospital General de Mexico | Completed | Met primary |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT01685281 Comparator | Aug → Dec 2013 | attention deficit hyperactivity disorder, inattentive type | Alcobra Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02019056 Comparator | Nov 2010 → Dec 2014 | alcoholic fatty liver disease, alcoholic hepatitis | PharmaKing | Completed | No outcome recorded |
| Phase 3 | NCT02477748 Comparator | Jun 2015 → Jan 2017 | attention deficit-hyperactivity disorder | Alcobra Ltd. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2011-09-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and Alcobra Announce Phase II Trial of Novel, Non-Stimulant MG01CI for ADHD Meets Primary Endpoint tevapharm.com ↗
Results showed MG01CI met the primary efficacy outcome, demonstrating a significant improvement on the Conners' Adult ADHD Rating Scale-Investigator Rated Total ADHD Symptoms Score (CAARS-INV) compared to placebo (p<0.03). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2011-09-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Alcobra Announce Phase II Trial of Novel, Non-Stimulant MG01CI for ADHD Meets Primary Endpoint tevapharm.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Metadoxine | “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...” NCT02477748 ↗11“Metadoxine (pyridoxol L-2-pyrrolidone-5-carboxylate)” NCT02126995 ↗ |
| Known as | MDX | “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...” NCT02477748 ↗1“OBJECTIVE: To assess the first-dose effectiveness and tolerability of metadoxine extended release (MDX) in adults with predominantly inattentive attention-deficit/hyperactivity...” PMID 25295645 ↗ Sep 2014 |
| Known as | Metadoxine (pyridoxol L-2-pyrrolidone-5-carboxylate) | “Metadoxine (pyridoxol L-2-pyrrolidone-5-carboxylate)” NCT02126995 ↗ |
| Known as | MG01CI | “MG01CI is an orally administered extended release formulation of metadoxine.” NCT01685281 ↗3“Metadoxine, MG01CI extended-release tablet taken for 6 weeks treatment.” NCT02126995 ↗ “single administration of MG01CI (Metadoxine Extended Release, MDX)” NCT02189772 ↗ “metadoxine (MG01CI) extended release formulation” NCT01243242 ↗ |
| Known as | MG01CI ,metadoxine | “MG01CI ,metadoxine” NCT01933997 ↗ |
| Known as | MTD | “To evaluate the impact of metadoxine (MTD) on the 3- and 6-mo survival of patients with severe alcoholic hepatitis (AH).” PMID 25945012 ↗ Apr 2015 |
| Known as | MTDX | “It is proposed to test metadoxine (MTDX) that it is hypothesized to be significantly beneficial for the treatment of alcoholism and ALD.” NCT01504295 ↗ |
| Route | Oral | “one oral 1400mg dose (2 tablets)” NCT00995085 ↗ |