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CLINICAL TRIALS PROFILE FOR VIGABATRIN
Clinical Trials for Vigabatrin
Trial ID | Title | Status | Sponsor | Phase | Summary |
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NCT00373581 | Effects of Vigabatrin on Cocaine Self-Administration | Terminated | Novel Cocaine Pharmacotherapies | Phase 2 | The objective of this study is to determine if vigabatrin will decrease cocaine self-administration, cardiovascular effects, subjective effects and craving compared to placebo. |
NCT00373581 | Effects of Vigabatrin on Cocaine Self-Administration | Terminated | New York State Psychiatric Institute | Phase 2 | The objective of this study is to determine if vigabatrin will decrease cocaine self-administration, cardiovascular effects, subjective effects and craving compared to placebo. |
NCT00441896 | A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms | Completed | Marinus Pharmaceuticals | Phase 2 | The study is a two period (8-10 days/period), incomplete cross-over in which successive cohorts of 9 subjects are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of 6 subjects, receives ascending doses of ganaxolone during period 1 and ganaxolone (at the maximal dose attained in period 1) and ascending doses of placebo during period 2. Sequence B, comprised of 3 subjects, receives ascending doses of placebo during period 1 and receives the maximum dose of placebo and ascending doses of ganaxolone during period 2. The dosing level in each subsequent cohort will be based upon experience gained from previous cohorts. |
NCT00506935 | Assessment of GVG for the Treatment of Methamphetamine Dependence | Completed | University of California, Los Angeles | Phase 1 | The purpose of this study is to find out if GVG can reduce drug use and determine safety and effects of GVG when used together with methamphetamine. This study involves staying in the hospital for 21 days. Participants will receive either placebo or GVG, and a limited amount if methamphetamine will be injected on some study days. This study will enroll people that use methamphetamine. Participants will be compensated. |
NCT00506935 | Assessment of GVG for the Treatment of Methamphetamine Dependence | Completed | National Institute on Drug Abuse (NIDA) | Phase 1 | The purpose of this study is to find out if GVG can reduce drug use and determine safety and effects of GVG when used together with methamphetamine. This study involves staying in the hospital for 21 days. Participants will receive either placebo or GVG, and a limited amount if methamphetamine will be injected on some study days. This study will enroll people that use methamphetamine. Participants will be compensated. |
NCT00527683 | Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence | Completed | Catalyst Pharmaceuticals, Inc. | Phase 2 | The primary objective of this study is to assess the efficacy of vigabatrin for the treatment of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine. Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject double- blind, randomized study is designed to show if with vigabatrin treatment but not placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine will become cocaine abstinent if they are self motivated to stop their cocaine habit. To accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase in the number of subjects who are abstinent for the final 3 weeks of the study. |
NCT00527683 | Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence | Completed | New York University School of Medicine | Phase 2 | The primary objective of this study is to assess the efficacy of vigabatrin for the treatment of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine. Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject double- blind, randomized study is designed to show if with vigabatrin treatment but not placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine will become cocaine abstinent if they are self motivated to stop their cocaine habit. To accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase in the number of subjects who are abstinent for the final 3 weeks of the study. |
Trial ID | Title | Status | Sponsor | Phase | Summary |
Clinical Trial Conditions for Vigabatrin
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