You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR FELBAMATE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Felbamate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00006773 ↗ Bortezomib in Treating Patients With Recurrent Glioma Terminated National Cancer Institute (NCI) Phase 1 2001-05-01 Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
NCT00034229 ↗ Clinical Trial of Felbamate for Treatment-Resistant Bipolar Depression Completed National Institute of Mental Health (NIMH) Phase 2 2002-04-01 The purpose of this study is to evaluate the safety and effectiveness of the drug felbamate for treating depression in patients with bipolar disorder that has not responded to standard treatments. Bipolar disorder is a severe, chronic, and often life-threatening illness. Despite the availability of a wide range of antidepressant drugs, a proportion of patients fail to respond to first-line antidepressant treatment despite adequate dosage, duration, and compliance. Studies suggest that the glutamatergic system may play a role in the pathophysiology and treatment of depression. Felbamate and other agents which reduce glutamatergic neurotransmission may represent a novel class of antidepressants. Participants in this study will be admitted to the Clinical Center for up to 10 weeks. At study entry, participants will have a 7-day washout period in which they will be tapered off all psychiatric medications, with the possible exception of lithium, and will be given a placebo (an inactive pill). After the washout period, participants will be randomly assigned to receive either felbamate or placebo for 8 weeks. Participants whose depression symptoms worsen by more than 30% or those for whom study continuation is considered potentially harmful will be taken off the study and offered open-label treatment. Participants who received felbamate and responded well to treatment will have the option of continuing treatment.
NCT00068770 ↗ Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT Terminated National Cancer Institute (NCI) Phase 2 2003-10-01 RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00068770 ↗ Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT Terminated Sidney Kimmel Comprehensive Cancer Center Phase 2 2003-10-01 RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Felbamate

Condition Name

Condition Name for Felbamate
Intervention Trials
Adult Gliosarcoma 1
Atrial Fibrillation 1
Bipolar Disorder 1
Brain and Central Nervous System Tumors 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Felbamate
Intervention Trials
Glioblastoma 2
Depression 1
Spasms, Infantile 1
Bipolar Disorder 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Felbamate

Trials by Country

Trials by Country for Felbamate
Location Trials
United States 20
Mexico 1
Brazil 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Felbamate
Location Trials
Maryland 3
Florida 2
Wisconsin 1
Washington 1
Virginia 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Felbamate

Clinical Trial Phase

Clinical Trial Phase for Felbamate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 3
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Felbamate
Clinical Trial Phase Trials
Completed 3
Terminated 2
Unknown status 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Felbamate

Sponsor Name

Sponsor Name for Felbamate
Sponsor Trials
National Cancer Institute (NCI) 2
Sidney Kimmel Comprehensive Cancer Center 1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Felbamate
Sponsor Trials
Other 5
NIH 3
Industry 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Felbamate: Clinical Trials, Market Analysis, and Projections

Introduction to Felbamate

Felbamate, also known as 2-phenyl-1,3-propanediol dicarbamate, is an antiepileptic drug used primarily in the treatment of partial seizures and Lennox-Gastaut syndrome. Here, we will delve into the recent clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Controlled Clinical Trials

Clinical trials have consistently shown that felbamate is effective in reducing seizure frequency. A double-blind, randomized, placebo-controlled trial involving patients with partial seizures demonstrated that felbamate was statistically superior to placebo in terms of seizure reduction, percent seizure reduction, and truncated percent seizure reduction. The trial included 56 patients who were already on therapeutic levels of phenytoin and carbamazepine, and the mean felbamate dosage was 2,300 mg/day[1].

In another set of trials, felbamate was compared to low-dose valproate as monotherapy in adults with partial-onset seizures. These trials showed that felbamate was more effective in reducing the percentage of patients meeting escape criteria, indicating better seizure control[4].

Adjunctive Therapy Trials

Felbamate has also been evaluated as an adjunctive therapy in patients with refractory partial-onset seizures. A double-blind, placebo-controlled crossover trial found that patients treated with felbamate had a significant reduction in seizure frequency compared to those treated with placebo. This trial highlighted a 23% difference in percentage seizure frequency reduction in favor of felbamate[4].

Safety and Adverse Effects

While felbamate has shown efficacy, it is also associated with serious side effects, including aplastic anemia and acute liver failure. The reported rate of liver failure in the U.S. is about 6 cases per 75,000 patient years of use, though this rate is likely an underestimate due to underreporting[4].

Market Analysis

Global Market Size and Growth

The global felbamate market is experiencing significant growth. As of 2023, the market size was substantial, and it is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2031. The tablet segment accounted for a noticeable share of the global felbamate market and is expected to continue growing[2].

Regional Analysis

The felbamate market has been segmented into major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region provides detailed insights into revenue share, current trends, and future market opportunities. The report includes data analysis at the country level as well as key regional trends[2].

Application Segments

Felbamate is primarily used in the treatment of partial-onset seizures and Lennox-Gastaut syndrome. The Refractory Lennox-Gastaut Syndrome segment is expected to expand significantly, retaining its position throughout the forecast period. Other key applications include adjunctive therapy for partial and generalized seizures[2].

Key Players

Companies such as Mylan and Amneal Pharmaceuticals are focusing on strengthening their product portfolios and expanding their business in the global felbamate market. These companies are adopting strategic models to enhance their market presence and capitalize on the growing demand for felbamate[2].

Market Projections

Forecasted Growth

The global felbamate market is forecasted to grow significantly from 2025 to 2031. The market size is estimated based on historical data from 2019 to 2023, with the base year being 2023. The report provides a detailed analysis of market trends, drivers, opportunities, and restraints that will influence the market growth during the forecast period[2].

Segment Analysis

The market has been segmented by type and application. The tablet segment is expected to dominate the market, while the Refractory Lennox-Gastaut Syndrome segment will see significant growth. The report provides quantitative and qualitative analysis of each type to understand the driving factors for the fastest-growing segments[2].

Technological and Regulatory Trends

The market analysis also includes technological trends, patent analysis, and regulatory insights. Recent clinical trials, such as those conducted by Instituto Nacional de Salud Publica, Mexico, and Laboratorios Grossman, S.A., are ongoing and may impact future market dynamics[3].

Challenges and Opportunities

Safety Concerns

Despite its efficacy, felbamate's market growth has been impacted by serious side effects. The risk of aplastic anemia and acute liver failure necessitates careful patient monitoring and has led to a cautious approach in its prescription[3].

Market Opportunities

The growing demand for effective antiepileptic drugs, especially for refractory cases, presents a significant opportunity for the felbamate market. Expanding into new regions and developing strategies to mitigate the risks associated with the drug can further enhance market growth[2].

Key Takeaways

  • Efficacy: Felbamate has been proven effective in reducing seizure frequency in patients with partial-onset seizures and Lennox-Gastaut syndrome.
  • Safety Concerns: Serious side effects such as aplastic anemia and acute liver failure are significant risks associated with felbamate.
  • Market Growth: The global felbamate market is projected to grow significantly from 2025 to 2031, driven by increasing demand and expanding into new regions.
  • Segment Analysis: The tablet segment and Refractory Lennox-Gastaut Syndrome segment are expected to dominate the market.
  • Regulatory and Technological Trends: Ongoing clinical trials and regulatory changes will continue to shape the market dynamics.

FAQs

What are the primary uses of felbamate?

Felbamate is primarily used in the treatment of partial-onset seizures and Lennox-Gastaut syndrome.

What are the serious side effects associated with felbamate?

Felbamate is associated with serious side effects including aplastic anemia and acute liver failure.

Which segment is expected to dominate the felbamate market?

The tablet segment is expected to dominate the felbamate market, while the Refractory Lennox-Gastaut Syndrome segment will see significant growth.

What is the projected growth rate of the global felbamate market?

The global felbamate market is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2031.

Which companies are key players in the felbamate market?

Companies such as Mylan and Amneal Pharmaceuticals are key players in the felbamate market, focusing on strengthening their product portfolios and expanding their business.

Sources

  1. Felbamate for partial seizures: results of a controlled clinical trial. PubMed.
  2. Felbamate Market Report 2024 (Global Edition). Cognitive Market Research.
  3. Generic FELBAMATE INN entry, drug patent and freedom to operate. Drug Patent Watch.
  4. Felbamate: Package Insert / Prescribing Information. Drugs.com.
  5. Felbamate - Market Research ReportsĀ® Inc.. Market Research Reports.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.