12 completed, 5 terminated, 5 withdrawn, 2 unknown. 12 Phase 2, 6 Phase 3, 4 Phase 4, 3 Phase 1, 2 Not applicable.
Follow Vigabatrin: new trials by email Literature Review of Vigabatrin trials Research Report on Vigabatrin
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 |
|---|---|---|---|---|---|---|
| Inhibiting GABA Transaminase to Relieve Obesity Induced Hyperinsulinemia and Insulin Resistance Vigabatrin Pill, Placebo oral tablet - Hyperinsulinism, Insulin Resistance | Phase 2 | Withdrawn | University of Arizona | 2030-04-15 | 2025-07-30 | |
| A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms AMZ002 injectable solution, 0.5mg/mL, Vigabatrin, oral - Spasms, Infantile | Phase 3 | Withdrawn | Amzell | 2023-04-01 | 2023-04-20 | |
| VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa Vigabatrin Only Product - Status Epilepticus, Electrographic, Coma | Phase 2 | Completed | University of Florida | 6 | 2021-09-22 | 2024-07-23 |
| Vigabatrin and Insulin Sensitivity Vigabatrin - NAFLD, Obesity | Phase 2 | Completed | Washington University School of Medicine | 4 | 2021-08-23 | 2025-01-14 |
| Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in Infants Vigabatrin, Rapamycin, Placebo - Tuberous Sclerosis Complex | Phase 2 / Phase 3 | Unknown | Katarzyna Kotulska | 60 | 2021-05-07 | 2024-02-08 |
| Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm Combination therapy with vigabatrin and prednisolone, Vigabatrin Tablets - Infantile Spasm, West Syndrome | Not applicable | Recruiting | Kullasate Sakpichaisakul | 250 | 2020-05-18 | 2021-08-25 |
| A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms Cannabidiol Oral Solution, Placebo, Vigabatrin - Infantile Spasm | Phase 3 | Terminated | Radius Pharmaceuticals, Inc. | 2 | 2018-09-05 | 2023-06-07 |
| A Novel Approach to Infantile Spasms Cosyntropin Injectable Suspension, 1 mg/mL, Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin, Vigabatrin - Infantile Spasm | Phase 3 | Suspended | University of Colorado, Denver | 394 | 2018-04-19 | 2021-05-27 |
| Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms Prednisolone, Vigabatrin - Infantile Spasms | Phase 3 | Withdrawn | The Hospital for Sick Children | 2017-09-05 | 2019-11-14 | |
| Population Pharmacokinetics of Antiepileptic in Pediatrics Valproic acid, carbamazepine, phenobarbital - Epilepsy | Completed | Assistance Publique - Hôpitaux de Paris | 753 | 2017-06-19 | 2025-11-20 | |
| Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex Early Vigabatrin, Delayed Vigabatrin (Placebo) - Tuberous Sclerosis Complex | Phase 2 | Completed | Martina Bebin | 84 | 2016-12-01 | 2024-08-19 |
| Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients Vigabatrin 500 MG - Autoimmune Encephalopathy | Not applicable | Withdrawn | Seoul National University Hospital | 2016-11-01 | 2021-09-29 | |
| Ketogenic Diet in Infants With Epilepsy (KIWE) Ketogenic diet, Antiepileptic drug therapy - Epilepsy | Phase 4 | Unknown | University College, London | 160 | 2015-01-01 | 2017-05-04 |
| Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette's Disorder vigabatrin - Tourette's Disorder | Phase 1 / Phase 2 | Completed | Barbara J. Coffey | 4 | 2012-07-01 | 2018-01-19 |
| An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms Vigabatrin - Infantile Spasms | Phase 4 | Withdrawn | Lundbeck LLC | 2012-06-01 | 2012-09-13 | |
| Vigabatrin for Cocaine and Alcohol Dependence Vigabatrin, Placebo - Alcoholism, Cocaine Dependence | Phase 2 | Terminated | University of Pennsylvania | 32 | 2011-04-01 | 2019-09-06 |
| Vigabatrin for the Treatment of Cocaine Dependency Vigabatrin, Matching Placebo - Cocaine Addiction, Cocaine Dependence | Phase 2 / Phase 3 | Completed | Catalyst Pharmaceuticals, Inc. | 207 | 2011-01-01 | 2016-05-18 |
| A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®) Sabril - Adult Refractory Complex Partial Seizures | Phase 4 | Completed | Lundbeck LLC | 65 | 2010-12-01 | 2016-06-07 |
| Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients vigabatrin - Complex Partial Seizures | Phase 4 | Terminated | University of Pennsylvania | 1 | 2010-08-01 | 2017-07-12 |
| Sabril Patient Registry Sabril® - Infantile Spasms, Refractory Complex Partial Seizures in Adults | Completed | Lundbeck LLC | 9423 | 2009-08-01 | 2016-07-29 |
Showing 20 of 26. Sign in to see all of them.
Spasms, Infantile (7) · Cocaine-Related Disorders (6) · Behavior, Addictive (4) · Epilepsy (4) · Seizures (4) · Tuberous Sclerosis (3) · Central Nervous System Diseases (2) · Alcoholism (1) · Autoimmune Diseases of the Nervous System (1) · Brain Diseases (1) · Coma (1) · Diabetes Mellitus, Type 2 (1) · Epilepsy, Complex Partial (1) · Epileptic Syndromes (1) · Glucose Intolerance (1)
Catalyst Pharmaceuticals, Inc. (3) · Lundbeck LLC (3) · University of Pennsylvania (2) · Amzell (1) · Assistance Publique - Hôpitaux de Paris (1) · Barbara J. Coffey (1) · Baylor College of Medicine (1) · Katarzyna Kotulska (1) · Kullasate Sakpichaisakul (1) · Martina Bebin (1) · NYU Langone Health (1) · National Institute on Drug Abuse (NIDA) (1) · New York State Psychiatric Institute (1) · Radius Pharmaceuticals, Inc. (1) · Seoul National University Hospital (1)
United States (16) · France (2) · Mexico (2) · Poland (2) · Argentina (1) · Canada (1) · India (1) · Italy (1) · South Korea (1) · Spain (1) · Thailand (1) · United Kingdom (1)
Ahmed Elkashef, M.D. (1) · Benjamin J Renquist, PhD (1) · Carolina B Maciel, MD, MSCR (1) · Carter Snead, MD (1) · Charles W Gorodetzky, MD, PhD (1) · Christopher J Stock, PharmD (1) · Emilia Figueroa, M.D. (1) · Eugene Somoza, MD, PhD (1) · Helen Cross, FRCP(UK) (1) · John D. Roache, Ph.D. (1) · John Pollard, MD (1) · Jonathan D Brodie, Ph.D., M.D. (1) · Jonathan D Brodie, PhD,MD (1)
PMID 10368073, PMID 10561962, PMID 10565592, PMID 11673582, PMID 12403260, PMID 14734931, PMID 15159460, PMID 15509243, PMID 15541450, PMID 18077226, PMID 19651710, PMID 20608959, PMID 21070215, PMID 22689735, PMID 22704138, PMID 22859699, PMID 23575810, PMID 24657009, PMID 26216500, PMID 26280806, PMID 26302697, PMID 27838190, PMID 28446244, PMID 29105055, PMID 29966811, PMID 31912454, PMID 35067230, PMID 37638552, PMID 40116235, PMID 4515986, PMID 6308515, PMID 6539199, PMID 8604274, PMID 8681895
P50DA012756 (1), U01NS092595 (1)