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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR ESLICARBAZEPINE ACETATE

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Clinical Trials for Eslicarbazepine Acetate

Trial ID Title Status Sponsor Phase 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 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 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 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 Active, not recruiting Sunovion Phase 3 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 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 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 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 Sponsor Phase Summary

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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 17
Seizures 10
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 122
Czech Republic 15
Portugal 14
Canada 7
Germany 7
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Trials by US State

Trials by US State for Eslicarbazepine Acetate
Location Trials
Florida 7
California 5
North Carolina 4
Kentucky 4
Louisiana 4
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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 3
Phase 3 13
Phase 2 10
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Clinical Trial Status

Clinical Trial Status for Eslicarbazepine Acetate
Clinical Trial Phase Trials
Completed 36
Terminated 5
Active, not recruiting 4
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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 50
Other 2
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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
US Army
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Johnson and Johnson
McKesson
Moodys
US Department of Justice
Julphar
Deloitte

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