8 completed, 1 unknown, 1 withdrawn. 5 Phase 2, 2 Phase 1, 2 Phase 4, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 5 |
| Phase 1 | 2 | Completed 2 |
| Phase 4 | 2 | Completed 1, Unknown 1 |
| Phase 3 | 1 | Withdrawn 1 |
Follow metadoxine: new trials by email Literature Review of metadoxine trials Research Report on metadoxine
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 |
|---|---|---|---|---|---|---|
| Effect of Metadoxine on Oxidative Stress in Non-alcoholic Hepatic Steatosis Metadoxine - NAFLD, Pre-diabetes | Phase 4 | Unknown | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | 100 | 2016-01-01 | 2019-01-31 |
| Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis metadoxine, placebo - Non-alcoholic Steatohepatitis | Phase 3 | Withdrawn | Hospital General de Mexico | 2015-08-01 | 2024-03-15 | |
| 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 |
| 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 |
| A Novel Pharmacotherapy for Alcoholism and Alcohol Liver Disease Metadoxine - Alcoholism,, Alcoholic Liver Disease | Phase 2 | Completed | Brown University | 38 | 2012-04-01 | 2015-07-22 |
| 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 and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis Placebo /bid P.O, MG-1, MG-2 : MG1000mg, Placebo /bid P.O - Alcoholic Fatty Liver Disease, Alcoholic Hepatitis | Phase 2 | Completed | PharmaKing | 90 | 2010-11-01 | 2015-04-29 |
| Metadoxine as a Therapy for Severe Alcoholic Hepatitis Prednisone plus Metadoxine, Pentoxifylline plus Metadoxine - Severe Alcoholic Hepatitis | Phase 4 | Completed | Hospital General de Mexico | 135 | 2010-04-01 | 2014-11-11 |
| 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 (3) · Hepatitis, Alcoholic (2) · Non-alcoholic Fatty Liver Disease (2) · Alcoholism (1) · Fatty Liver, Alcoholic (1) · Fragile X Syndrome (1) · Glucose Intolerance (1) · Liver Diseases, Alcoholic (1) · Syndrome (1)
Alcobra Ltd. (5) · Hospital General de Mexico (2) · Brown University (1) · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (1) · PharmaKing (1)
Israel (5) · Mexico (3) · United States (2) · South Korea (1)
Iris Manor, MD (2) · Aldo Torre, MD MSci (1) · Elizabeth Berry-Kravis, MD, PhD (1) · Fatima Higuera-de la Tijera, MD, MSc. (1) · George A Kenna, PhD RPh (1) · Iris Manor, Dr. (1) · Jacob Atsmon, Dr. (1)
PMID 23290324, PMID 23933905, PMID 25295645, PMID 25945012
R21AA021128 (1)