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Last Updated: June 7, 2020

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CLINICAL TRIALS PROFILE FOR SABRIL

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505(b)(2) Clinical Trials for Sabril

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT02220114 Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy Recruiting Hospices Civils de Lyon N/A 2014-05-01 The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets (for infants and children below 6 years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often required. This study is a descriptive, non-randomized, open label multi-centric acceptability study in infants and children affected with infantile spasms. The primary objective is to describe the adherence to the new formulation. Secondary objectives include: - evaluation of the palatability and user-friendliness of the new treatment, - evaluation of the pharmacokinetic parameters of the new formulation, - PK parameters, - evaluation of the tolerance, - measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.
New Formulation NCT02220114 Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy Recruiting Institut National de la Santé Et de la Recherche Médicale, France N/A 2014-05-01 The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets (for infants and children below 6 years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often required. This study is a descriptive, non-randomized, open label multi-centric acceptability study in infants and children affected with infantile spasms. The primary objective is to describe the adherence to the new formulation. Secondary objectives include: - evaluation of the palatability and user-friendliness of the new treatment, - evaluation of the pharmacokinetic parameters of the new formulation, - PK parameters, - evaluation of the tolerance, - measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.
New Formulation NCT02220114 Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy Recruiting National Research Agency, France N/A 2014-05-01 The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets (for infants and children below 6 years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often required. This study is a descriptive, non-randomized, open label multi-centric acceptability study in infants and children affected with infantile spasms. The primary objective is to describe the adherence to the new formulation. Secondary objectives include: - evaluation of the palatability and user-friendliness of the new treatment, - evaluation of the pharmacokinetic parameters of the new formulation, - PK parameters, - evaluation of the tolerance, - measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.
New Formulation NCT02220114 Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy Recruiting Targeon SAS N/A 2014-05-01 The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets (for infants and children below 6 years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often required. This study is a descriptive, non-randomized, open label multi-centric acceptability study in infants and children affected with infantile spasms. The primary objective is to describe the adherence to the new formulation. Secondary objectives include: - evaluation of the palatability and user-friendliness of the new treatment, - evaluation of the pharmacokinetic parameters of the new formulation, - PK parameters, - evaluation of the tolerance, - measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Sabril

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00527683 Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence Completed Catalyst Pharmaceuticals, Inc. Phase 2 2007-04-01 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 2007-04-01 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.
NCT01073579 Sabril Patient Registry Completed Lundbeck LLC N/A 2009-08-01 The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with Sabril and the prescribers of Sabril.
NCT01266291 Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients Terminated University of Pennsylvania Phase 4 2010-08-01 This is an open-label, phase 4 study to examine the safety and efficacy of vigabatrin (Sabril) in Tuberous Sclerosis patients, a subset of the larger refractory complex partial epilepsy population for which the drug is approved. While enrolled on this trial, subjects will continue to take all of their normally prescribed medications, including their other antiepileptic drugs (AEDs). Alternatively, there is a prospective observational arm that subjects who are about to take Sabril as treatment for seizures associated with Tuberous Sclerosis may join. Subjects who join this arm will not have any study visits and will not be asked to do anything specifically for the study. The study team will collect all study data from subjects' medical records only.
NCT01278173 A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®) Completed Lundbeck LLC Phase 4 2010-12-01 The purpose of the study is to evaluate the change in visual fields by means of automated static perimetry and to evaluate the change in retinal structure by means of spectral domain optical coherence tomography (SD-OCT) in adult patients with refractory complex partial seizures (CPS) being treated with vigabatrin (Sabril®)
NCT01335867 Vigabatrin for Cocaine and Alcohol Dependence Terminated National Institute on Drug Abuse (NIDA) Phase 2 2011-04-01 The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug and alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.
NCT01335867 Vigabatrin for Cocaine and Alcohol Dependence Terminated University of Pennsylvania Phase 2 2011-04-01 The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug and alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sabril

Condition Name

Condition Name for Sabril
Intervention Trials
Infantile Spasms 3
Infantile Spasm 2
Cocaine Dependence 2
Adult Refractory Complex Partial Seizures 1
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Condition MeSH

Condition MeSH for Sabril
Intervention Trials
Spasms, Infantile 5
Spasm 5
Seizures 3
Cocaine-Related Disorders 2
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Clinical Trial Locations for Sabril

Trials by Country

Trials by Country for Sabril
Location Trials
United States 30
Mexico 1
Canada 1
France 1
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Trials by US State

Trials by US State for Sabril
Location Trials
Pennsylvania 3
Texas 2
Oregon 2
Minnesota 2
Florida 2
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Clinical Trial Progress for Sabril

Clinical Trial Phase

Clinical Trial Phase for Sabril
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Sabril
Clinical Trial Phase Trials
Completed 3
Not yet recruiting 3
Recruiting 3
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Clinical Trial Sponsors for Sabril

Sponsor Name

Sponsor Name for Sabril
Sponsor Trials
University of Pennsylvania 2
Lundbeck LLC 2
Kullasate Sakpichaisakul 1
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Sponsor Type

Sponsor Type for Sabril
Sponsor Trials
Other 10
Industry 5
NIH 2
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