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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR ESLICARBAZEPINE ACETATE


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All Clinical Trials for Eslicarbazepine Acetate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00866775 ↗ Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs Completed Sunovion Phase 3 2009-04-01 This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.
NCT00898560 ↗ Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive Completed Bial - Portela C S.A. Phase 1 2008-09-01 The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
NCT00900237 ↗ Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine Completed Bial - Portela C S.A. Phase 1 2008-11-01 This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated.
NCT00910247 ↗ Eslicarbazepine Acetate Monotherapy Long Term Study Completed Sunovion Phase 3 2009-08-01 This is a long term, open-label, safety extension study in subjects with partial onset seizures.
NCT00957047 ↗ Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy Completed Bial - Portela C S.A. Phase 3 2004-07-01 The primary objective of the study is to evaluate the efficacy of eslicarbazepine acetate once-daily at doses of 400 mg, 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period. Patients who complete Part I may enter a 1-year open-label extension.
NCT00957372 ↗ Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy Completed Bial - Portela C S.A. Phase 3 2004-12-01 The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL) administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period.
NCT00957684 ↗ Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures Completed Bial - Portela C S.A. Phase 3 2004-07-01 This was a phase III 4-part study in multiple centres. Part I was a 26-week parallel-group, randomised, placebo-controlled period (8 weeks single-blind placebo baseline, 2 weeks double-blind titration, 12 weeks maintenance, and 4 weeks tapering off). After completing the baseline period, patients were randomised in a 1:1:1:1 ratio to 1 of 3 ESL dose levels or to placebo. Part II was a 1-year open-label extension for patients who had completed Part I. The starting dose was 800 mg once daily and could be titrated up or down at 400-mg intervals between 400 and 1200 mg. Part III was an additional 1-year open-label extension for patients who had completed Part II, had participated in the post-Part II study extension, which allowed patients to continue treatment with ESL, or had continued to take ESL in a compassionate use program. ESL starting doses were the same as received at the end of Part II, during post-Part II study extension, or under compassionate use, and could be titrated up or down at 400-mg intervals between 400 and 1200 mg once daily. Part IV was a study extension to allow patients to continue ESL treatment after the end of Part III until marketing authorisation or discontinuation of clinical development.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Eslicarbazepine Acetate

Condition Name

Condition Name for Eslicarbazepine Acetate
Intervention Trials
Epilepsy 29
Partial Epilepsy 6
Bipolar I Disorder 3
Painful Diabetic Neuropathy 2
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Condition MeSH

Condition MeSH for Eslicarbazepine Acetate
Intervention Trials
Epilepsy 38
Seizures 11
Epilepsies, Partial 10
Neuralgia 4
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Clinical Trial Locations for Eslicarbazepine Acetate

Trials by Country

Trials by Country for Eslicarbazepine Acetate
Location Trials
United States 151
Czech Republic 15
Portugal 14
Canada 9
Czechia 8
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Trials by US State

Trials by US State for Eslicarbazepine Acetate
Location Trials
Florida 8
California 6
Texas 5
Pennsylvania 5
Oklahoma 5
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Clinical Trial Progress for Eslicarbazepine Acetate

Clinical Trial Phase

Clinical Trial Phase for Eslicarbazepine Acetate
Clinical Trial Phase Trials
Phase 4 2
Phase 3 14
Phase 2 10
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Clinical Trial Status

Clinical Trial Status for Eslicarbazepine Acetate
Clinical Trial Phase Trials
Completed 45
Terminated 4
Unknown status 1
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Clinical Trial Sponsors for Eslicarbazepine Acetate

Sponsor Name

Sponsor Name for Eslicarbazepine Acetate
Sponsor Trials
Bial - Portela C S.A. 42
Sunovion 7
Eisai Inc. 1
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Sponsor Type

Sponsor Type for Eslicarbazepine Acetate
Sponsor Trials
Industry 51
Other 2
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Eslicarbazepine Acetate: Clinical Trials, Market Analysis, and Projections

Introduction

Eslicarbazepine acetate, marketed under the brand name Zebinix, is an anticonvulsant medication used as an adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Phase 3 Trials

Eslicarbazepine acetate has undergone extensive clinical trials to establish its efficacy and safety. The phase 3 trials, identified by the investigational drug name BIA-2093, included three multicentre, randomised, double-blind, placebo-controlled studies (BIA-2093-301, BIA-2093-302, and BIA-2093-303)[4].

  • Patient Population: These studies involved adult patients experiencing simple or complex partial seizures with or without secondary generalisation, despite treatment with up to three concomitant antiepileptic drugs (AEDs)[3].
  • Trial Design: The trials consisted of an eight-week baseline period, a two-week titration period, and a twelve-week maintenance phase. Patients who completed the double-blind treatment period were eligible to enter open-label, 1-year extension studies[4].

Efficacy Outcomes

The clinical trials demonstrated that eslicarbazepine acetate is effective in reducing the frequency of partial-onset seizures. The studies showed that eslicarbazepine acetate was generally well tolerated and had a low potential for drug-drug interactions[4].

  • Long-term Efficacy: The open-label extension studies provided data on the long-term efficacy and safety of eslicarbazepine acetate. For example, the extension study to BIA-2093-302 showed that patients receiving eslicarbazepine acetate for up to one year maintained significant seizure reduction[4].

Safety Profile

The safety profile of eslicarbazepine acetate was evaluated in these trials, with treatment-emergent adverse events reported by 38% to 80% of recipients, compared to 31% to 45% of placebo recipients. Most adverse events were mild to moderate, with severe events reported in 0% to 6% of eslicarbazepine acetate recipients[4].

Mechanism of Action

Eslicarbazepine acetate is a prodrug that is rapidly converted to its primary active metabolite, eslicarbazepine. The mechanism of action involves the inhibition of repeated neuronal firing by stabilizing the inactivated state of voltage-gated sodium channels and preventing their return to the activated state. Additionally, eslicarbazepine inhibits T-type calcium channels, which also contributes to its anticonvulsant activity[1].

Market Analysis

Global Market Size and Growth

The global eslicarbazepine acetate reagent market is projected to experience significant growth. As of 2023, the market size was notable, and it is expected to continue growing at a compound annual growth rate (CAGR) from 2024 to 2031[2].

  • Segment Analysis: The market is segmented by type, application, and region. The research segment is expected to expand significantly during the forecast period, driven by the increasing demand for high-quality and environment-friendly products in various end-use sectors[2].

Key Players and Strategies

Major companies such as TCI and LGC are focusing on strengthening their product portfolios and expanding their business in the global market. These companies are investing in technological advancements to produce high-quality chemicals, which is a key driver for market growth[2].

Regional Analysis

The market analysis includes regional insights, with North America, Europe, Asia Pacific, South America, and the Middle East and Africa being key regions. Each region's market size, growth rate, and competitive landscape are analyzed to provide a comprehensive understanding of the global market[2].

Market Projections

Patient Uptake and Budget Impact

Estimates suggest that eslicarbazepine acetate will partly displace other antiepileptic drugs, leading to an anticipated uptake that will increase over the next few years. For example, an estimated number of patients are likely to be prescribed eslicarbazepine acetate in the initial year, increasing significantly by the fifth year. This will result in net medicine acquisition costs that are expected to rise accordingly[3].

Cost-Effectiveness

Studies have compared the cost-effectiveness of eslicarbazepine acetate with other AEDs, such as lacosamide. The analysis suggests that eslicarbazepine acetate and lacosamide have comparable efficacy and cost-effectiveness. Probabilistic sensitivity analyses indicate that eslicarbazepine acetate treatment is cost-effective at thresholds of £20,000 to £30,000 per quality-adjusted life-year (QALY) gained[3].

Regulatory and Approval Status

Eslicarbazepine acetate has been approved for use in Europe, the United States, and Canada as an adjunctive therapy for partial-onset seizures. The FDA accepted a New Drug Application for eslicarbazepine acetate in June 2009 and approved it for formal review by January 2010[4].

Conclusion

Eslicarbazepine acetate has demonstrated efficacy and safety in clinical trials, making it a valuable adjunctive therapy for partial-onset seizures. The market analysis indicates a growing demand for this drug, driven by its low potential for drug-drug interactions and its cost-effectiveness compared to other AEDs. As the global market continues to expand, eslicarbazepine acetate is poised to play a significant role in the treatment of epilepsy.

Key Takeaways

  • Clinical Efficacy: Eslicarbazepine acetate has shown significant efficacy in reducing partial-onset seizures in clinical trials.
  • Safety Profile: The drug is generally well tolerated with a low potential for severe adverse events.
  • Market Growth: The global eslicarbazepine acetate reagent market is projected to grow significantly from 2024 to 2031.
  • Cost-Effectiveness: Eslicarbazepine acetate is cost-effective compared to other AEDs like lacosamide.
  • Regulatory Approval: Approved for use in Europe, the United States, and Canada as an adjunctive therapy for partial-onset seizures.

FAQs

What is the primary mechanism of action of eslicarbazepine acetate?

Eslicarbazepine acetate works by inhibiting repeated neuronal firing through the stabilization of the inactivated state of voltage-gated sodium channels and by inhibiting T-type calcium channels[1].

Which regions are key in the global eslicarbazepine acetate reagent market?

The key regions include North America, Europe, Asia Pacific, South America, and the Middle East and Africa[2].

What are the common adverse events associated with eslicarbazepine acetate?

Common adverse events include dizziness, nausea, vomiting, somnolence, and mild to moderate elevations in transaminases. Severe adverse events are rare but can include hyponatremia and drug-induced liver injury[1][4].

How does eslicarbazepine acetate compare to other antiepileptic drugs in terms of cost-effectiveness?

Eslicarbazepine acetate has been shown to have comparable efficacy and cost-effectiveness to other AEDs like lacosamide, with positive incremental cost-effectiveness ratios per QALY gained[3].

What is the projected market growth for eslicarbazepine acetate from 2024 to 2031?

The global eslicarbazepine acetate reagent market is expected to grow at a significant CAGR from 2024 to 2031, driven by increasing demand and technological advancements[2].

Sources

  1. DrugBank: Eslicarbazepine acetate: Uses, Interactions, Mechanism of Action.
  2. Cognitive Market Research: Eslicarbazepine Acetate Reagent Market Report 2024 (Global Edition).
  3. AWTTC: Limited submission Eslicarbazepine acetate (Zebinix®) 200 mg and 800 mg film-coated tablets.
  4. Managed Healthcare Executive: Eslicarbazepine: A novel antiepileptic agent designed for improved efficacy and safety.

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