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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00744731
Other study ID # 333369EPY3014
Secondary ID CARISEPY3014
Status Completed
Phase Phase 3
First received August 29, 2008
Last updated June 10, 2013
Start date January 2009
Est. completion date August 2010

Study information

Verified date June 2013
Source SK Life Science
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

CARISEPY3014 is the open-label extension study that follows the double-blind study CARISEPY3013 (NCT00740623). In an open label study such as CARISEPY3014, both the physician and the patient know the name of the assigned study medication. In a double blind study such as CARISEPY-3013, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the 14-week double-blind treatment phase of study CARISEPY3013 will be eligible to enter the open-label extension study during which patients will transition through a 1-week blinded period to open-label carisbamate. There will be a 1 week blinded transition during which patients will take blinded study medication; after this, patients will then take unblinded, open-label study medication. Safety assessments include 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, the Physician Withdrawal Checklist for symptoms of withdrawal for those patients who taper and/or discontinue study drug, and pregnancy tests for females of childbearing potential. Seizure counts will be obtained at every visit. The Quality of Life in Epilepsy-31 Patient Inventory questionnaire will be administered once during the study. A Medical Resource utilization questionnaire will be used to obtain cost-effectiveness information on carisbamate and will be administered twice during the study. There is no statistical testing hypothesis for this study. Carisbamate tablets taken twice daily in 2 equally divided doses, with or without food, and taken with noncarbonated water. During the first week on study, patients will take blinded transition study medication and thereafter will take a target dosage of 800 mg/day of unblinded, open-label study medication. The dosage of study medication will range from 400 to 1,200 mg/day. Patients will receive treatment for 1 year with the potential to receive treatment longer.


Recruitment information / eligibility

Status Completed
Enrollment 403
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
placebo
placebo for 1 week
carisbamate
400 mg/day to 1,200 mg per day

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
SK Life Science

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
See also
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Completed NCT00433667 - A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures. Phase 3
Completed NCT00425282 - A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures. Phase 3
Completed NCT03156439 - Bioavailability, Safety, and Tolerability of BIS-001 ER Phase 1
Completed NCT04573569 - Neural Correlates of Cognition and Mood
Completed NCT00740623 - A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures. Phase 3
Completed NCT00319501 - Efficacy and Safety of Vanquix for the Management of Selected, Refractory, Patients With Epilepsy Who Require Intermittent Caregiver Medical Intervention to Control Episodes of Acute Repetitive Seizures. Phase 3
Completed NCT00991757 - An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures. Phase 3
Completed NCT00056576 - Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy Phase 3
Terminated NCT01128712 - Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin Phase 4