A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures.

NCT00740623 | Completed Phase 3

• 2 other identifiers: CR015463CARISEPY3013
• Study Type: interventional
• Target: 547
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy.

Conditions

Epilepsy, Partial, Motor; Epilepsy, Complex Partial; Epilepsy, Simple Partial; Focal Motor Epilepsy

Keywords

Partial Onset Seizures; Simple Partial Seizures; Complex Partial Seizures

Outcome Measures

Primary Outcomes (1)

• Primary efficacy endpoints are percent reduction in partial onset seizure frequency in the US and the rest of the world (excluding Europe, Australia, New Zealand, S Africa), and responder rate for Europe, Australia, New Zealand, S Africa

  from baseline relative to the entire double-blind treatment phase (14 weeks)

Secondary Outcomes (1)

• Secondary endpoints are percent reduction in partial onset seizure frequency for EuropeAustraliaNew Zealand S Africa, percent reduction in secondarily generalized seizure and time to onset of treatment effect on partial onset seizure frequency reduction

  from baseline relative to the entire double-blind treatment phase (14 weeks)

Study Arms (3)

001

EXPERIMENTAL

Carisbamate 800 mg/day for 14 weeks

Drug: Carisbamate

002

EXPERIMENTAL

Carisbamate 1,200 mg/day for 14 weeks

Drug: Carisbamate

003

PLACEBO COMPARATOR

placebo for 14 weeks

Drug: placebo

Interventions

Carisbamate DRUG

800 mg/day for 14 weeks

001

placebo DRUG

placebo for 14 weeks

003

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of partial onset seizures
• had a neuroimaging procedure (computed tomography \[CT\] or magnetic resonance imaging \[MRI\] within the past 5 years that excluded a progressive neurologic disorder
• History of inadequate response to at least 1 antiepileptic drug
• Current treatment with at least 1 and up to 3 antiepileptic drugs. To be eligible for the double-blind treatment phase of study CARISEPY3013, patients must: have at least 6 partial onset seizures during the 56-day baseline period
• Have not had \> = 100 partial onset seizures per 28 days in the baseline period
• And no seizure-free period of more than 3 weeks during the baseline period.

You may not qualify if:

• History of status epilepticus or epilepsia partialis continua in the 6 months before study entry
• Have a generalized epileptic syndrome
• have a diagnosis of Lennox-Gastaut Syndrome
• Currently experiencing seizures that cannot be counted accurately
• have experienced rates of \> = 100 partial onset seizures in any monthly period in the 6 months before study entry
• Have a history of any current or past nonepileptic seizures, including psychogenic seizures
• History of or current serious or medically unstable systemic disease
• evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome, or significant shortening or lengthening of the QTc interval of the electrocardiogram
• progressive neurologic disorder, such as a brain tumor, demyelinating disease, and degenerative CNS disease, or active CNS infection
• current or past (within the past year) major psychotic disorder
• History of suicidal or homicidal ideation within the past 2 years, or an episode of suicide attempt or homicide at any time in the past.

Sponsors & Collaborators

• SK Life Science, Inc.: lead

Related Publications (2)

• Lu C, Zheng J, Cao Y, Bresnahan R, Martin-McGill KJ. Carisbamate add-on therapy for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD012121. doi: 10.1002/14651858.CD012121.pub2.

  PMID: 34870321 DERIVED

• Halford JJ, Ben-Menachem E, Kwan P, Ness S, Schmitt J, Eerdekens M, Novak G. A randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of adjunctive carisbamate treatment in patients with partial-onset seizures. Epilepsia. 2011 Apr;52(4):816-25. doi: 10.1111/j.1528-1167.2010.02960.x. Epub 2011 Feb 14.

  PMID: 21320109 DERIVED

MeSH Terms

Conditions

Epilepsy, Partial, Motor; Epilepsy, Complex Partial; Epilepsies, Partial; Seizures

Interventions

S-2-O-carbamoyl-1-o-chlorophenyl-ethanol

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 25, 2008
• Study Start: January 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: April 1, 2010
• Last Updated: January 24, 2013

Record last verified: 2013-01