An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures

NCT00744731 | Completed Phase 3

• 2 other identifiers: 333369EPY3014CARISEPY3014
• Study Type: interventional
• Target: 403
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to obtain long-term safety and tolerability information on carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy. Seizure counts will be obtained to measure the rate of seizures for each patient during the study.

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)

• Safety will be evaluated by the monitoring of the frequency, severity, and timing of adverse events, clinical laboratory test results, 12-lead electrocardiogram (ECG) recordings, vital signs measurements, physical and neurologic examinations

  after a stable dose of Carisbamate is achieved, study visits to assess safety will be every three months for the duration of the subject's participation; subjects will also maintain a seizure count diary

Secondary Outcomes (1)

• To evaluate the impact of carisbamate on subject functioning and well being using the QOLIE-31 Patient Inventory (as exploratory). Administered at month 3 and end of study.

  after a stable dose of Carisbamate is achieved, study visits to assess safety will be every three months for the duration of the subject's participation; subjects will also maintain a seizure count diary

Study Arms (2)

001

EXPERIMENTAL

placebo placebo for 1 week

Drug: placebo

002

EXPERIMENTAL

carisbamate 400 mg/day to 1,200 mg per day

Drug: carisbamate

Interventions

placebo DRUG

placebo for 1 week

001

carisbamate DRUG

400 mg/day to 1,200 mg per day

002

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:

• Must have completed the 14-week double-blind treatment phase of study CARISEPY3013
• must be willing/able to follow the restrictions and prohibitions of the protocol
• must be able to complete the patient diaries correctly (patients or legally acceptable representatives)
• must sign an informed consent form indicating agreement to participate in the study (patients or legally acceptable representatives)
• adolescents capable of understanding the nature of the study must provide assent to participate in the study

You may not qualify if:

• Patients who have not completed the 14-week double-blind treatment phase of study CARISEPY3013.

Sponsors & Collaborators

• SK Life Science, Inc.: lead

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: January 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 18, 2013

Record last verified: 2013-06