CLINICAL TRIALS PROFILE FOR SABRIL

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	Completed	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	Completed	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	Completed	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	Completed	Orphelia Pharma	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	Completed	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.
New Formulation	NCT04468282 ↗	Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration	Completed	Orphelia Pharma	Phase 1	2017-04-04	Methodology: The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash out period between administrations

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.
NCT00527683 ↗	Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence	Completed	NYU Langone Health	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		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	H. Lundbeck A/S	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.
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.

Clinical Trial Conditions for Sabril

Condition Name

Condition Name for Sabril
Intervention	Trials
Infantile Spasms	3
Cocaine Dependence	2
Infantile Spasm	2
Therapeutic Equivalency	1

Condition MeSH

Condition MeSH for Sabril
Intervention	Trials
Spasms, Infantile	5
Spasm	5
Seizures	3
Epilepsy	2

Clinical Trial Locations for Sabril

Trials by Country

Trials by Country for Sabril
Location	Trials
United States	37
France	2
Mexico	1
Canada	1
Thailand	1

Trials by US State

Trials by US State for Sabril
Location	Trials
Pennsylvania	4
California	2
Washington	2
Ohio	2
Michigan	2

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

Clinical Trial Status

Clinical Trial Status for Sabril
Clinical Trial Phase	Trials
Completed	5
Terminated	3
Active, not recruiting	1

Clinical Trial Sponsors for Sabril

Sponsor Name

Sponsor Name for Sabril
Sponsor	Trials
Orphelia Pharma	2
Lundbeck LLC	2
University of Pennsylvania	2

Sponsor Type

Sponsor Type for Sabril
Sponsor	Trials
Other	11
Industry	9
NIH	2

SABRIL (Vigabatrin): Clinical Trials, Market Analysis, and Projections

Introduction to SABRIL (Vigabatrin)

SABRIL, known generically as vigabatrin, is an antiepileptic drug used primarily for the treatment of certain types of seizures, including infantile spasms and refractory complex partial seizures. Here, we will delve into the current clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Usage

Current Clinical Trials Context

While there are no new clinical trials specifically focused on SABRIL itself, it is often compared and used in studies to evaluate other formulations or treatments. For instance, a recent usability study compared the administration of vigabatrin oral solution (PRODUCT X) to the FDA-approved SABRIL powder for oral solution. This study highlighted that the ready-to-use vigabatrin oral solution had fewer use errors and was easier to administer than the SABRIL powder, ensuring a more accurate dose delivery[4].

Historical Clinical Trials

SABRIL has undergone extensive clinical testing in the past. It is approved for adjunctive therapy in adult patients with refractory complex partial seizures and for the treatment of infantile spasms. Clinical trials have shown that vigabatrin is effective in reducing the frequency of seizures, although it comes with significant side effects, such as visual field defects[3].

Market Analysis

Global Epilepsy Drugs Market

The global epilepsy drugs market, which includes SABRIL, is projected to grow significantly. By 2025, the market is expected to cross the $9 billion mark, driven by the increasing prevalence of epilepsy and the need for effective treatments[5].

Market Size and Growth Rate

The broader epilepsy therapeutics market is anticipated to reach $15.1 billion by 2030, growing at a CAGR of 4.5% from 2022 to 2030. North America is the largest market, while the Asia Pacific region is expected to be the fastest-growing market during this period[2].

Market Segmentation

The epilepsy drugs market is segmented by product, distribution channel, and region. SABRIL falls under the category of second-generation antiepileptic drugs, which are widely used due to their efficacy and relatively better side effect profile compared to first-generation drugs[5].

Key Drugs in the Market

SABRIL (Vigabatrin) and Other Competitors

SABRIL competes with other antiepileptic drugs such as Vimpat (Lacosamide), Keppra (Levetiracetam), Onfi (Clobazam), and Fycompa. Each of these drugs has its own strengths and is used for different types of seizures, making the market diverse and competitive[5].

Safety and Efficacy

Safety Profile

Vigabatrin has a well-documented safety profile, although it is associated with significant side effects. The most notable is the risk of visual field defects, which affects a substantial portion of patients. However, it does not prolong the QT interval, a critical factor in cardiac safety[3].

Efficacy in Seizure Control

Clinical trials have demonstrated that vigabatrin is effective in reducing the frequency and severity of seizures. It is particularly useful in cases where other treatments have failed, making it a valuable option for patients with refractory epilepsy[3].

Future Projections

Market Trends

The epilepsy therapeutics market is expected to continue growing due to advancements in drug development and an increasing awareness of epilepsy. New formulations and delivery methods, such as the ready-to-use vigabatrin oral solution, are likely to improve patient compliance and outcomes[2].

Emerging Treatments

While SABRIL remains a crucial treatment option, the market is also seeing the emergence of new treatments. For example, the Galene clinical trial, focused on TSC-related epilepsy, is exploring the potential of basimglurant, a drug that could offer a new treatment pathway for patients with tuberous sclerosis complex (TSC)[1].

Key Takeaways

• Clinical Trials: SABRIL has been extensively tested and is compared in usability studies to improve administration accuracy.
• Market Analysis: The global epilepsy drugs market is projected to grow, with SABRIL being a significant player.
• Safety and Efficacy: Vigabatrin is effective but comes with notable side effects, particularly visual field defects.
• Future Projections: The market will continue to grow with advancements in drug development and new treatment options.

FAQs

What is SABRIL used for?

SABRIL (vigabatrin) is used for the treatment of infantile spasms and refractory complex partial seizures.

What are the common side effects of SABRIL?

The most significant side effect of SABRIL is the risk of visual field defects. Other side effects include nervous system disorders.

How does SABRIL compare to other antiepileptic drugs?

SABRIL competes with other second-generation antiepileptic drugs like Vimpat, Keppra, and Onfi, each with its own efficacy and side effect profile.

What is the current market size of the epilepsy therapeutics market?

The global epilepsy therapeutics market is expected to reach $15.1 billion by 2030.

Are there any new clinical trials related to SABRIL?

While there are no new clinical trials specifically for SABRIL, it is often used as a comparator in studies evaluating new formulations or treatments.

Sources

1. Tuberous Sclerosis Alliance: "Participants needed for important TSC-related epilepsy clinical trial" - https://tuberous-sclerosis.org/galene-clinical-trial/
2. Biospace: "Epilepsy Therapeutics Market worth $ 15.1 Bn by 2030 at a CAGR of 4.5 percent" - https://www.biospace.com/epilepsy-therapeutics-market-worth-15-1-bn-by-2030-at-a-cagr-of-4-5-percent
3. FDA: "CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW" - https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022006s000_ClinPharm.pdf
4. AES Net: "Comparison of Vigabatrin Oral Solution versus Sabril Powder for Oral Solution in Infantile Spasms by Caregivers" - https://aesnet.org/abstractslisting/comparison-of-vigabatrin-oral-solution-versus-sabril-powder-for-oral-solution-in-infantile-spasms-by-caregivers
5. EIN Presswire: "Global Epilepsy Drugs Market 2013-2019 & 2025 by Drugs (Vimpat, Keppra, Sabril, Onfi, etc), Treatment Drugs Generation (First, Second, Third), Companies & Forecasts" - https://www.einpresswire.com/article/476844202/global-epilepsy-drugs-market-2013-2019-2025-by-drugs-vimpat-keppra-sabril-onfi-etc-treatment-drugs-generation-first-second-third