Open-Label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial - Full Text View

Sponsored by:	Valeant Pharmaceuticals North America
Information provided by:	Valeant Pharmaceuticals North America
ClinicalTrials.gov Identifier:	NCT00310375

Purpose

The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.

Condition	Intervention	Phase
Epilepsies, Partial	Drug: Retigabine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label, Long-Term, Safety, Tolerability and Efficacy Study of Retigabine in Adult Epilepsy Patients With Partial-Onset Seizures (Extension of Study VRX-RET-E22-301)

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: D 23129

U.S. FDA Resources

Further study details as provided by Valeant Pharmaceuticals North America:

Primary Outcome Measures:

Percentage change in the monthly seizure rate from the baseline phase to the open-label treatment phase. [ Time Frame: Frequency rates to be determined at end of the open-label treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reports of adverse events [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
Results of vital signs [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
Weight [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
Clinical laboratory evaluations [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
12-lead ECG [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
Post-void residual bladder ultrasounds [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	280
Study Start Date:	May 2006
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Retigabine: Experimental	Drug: Retigabine Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.

Detailed Description:

This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-301 trial. Patients who have completed the VRX-RET-E22-301 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until retigabine is commercially available, or until the program is discontinued. Patients will be recruited from 45-50 sites in the United States, Canada, Mexico, Brazil, and Argentina. The safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine and patient quality of life will be assessed.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-301 for the treatment of partial-onset seizures
Patient is expected to benefit from participation in the study in the opinion of the Investigator.

Exclusion Criteria:

Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or is experiencing an ongoing serious adverse event.
Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition.
Patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310375

Show 49 Study Locations

Sponsors and Collaborators

Valeant Pharmaceuticals North America

More Information

No publications provided

Responsible Party:	Valeant Pharmaceuticals ( Hank Mansbach, MD )
Study ID Numbers:	VRX-RET-E22-303
Study First Received:	March 30, 2006
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00310375 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals North America:

Partial Seizures
Complex Partial Seizures
Epilepsy
Anticonvulsant
Potassium Channels

Study placed in the following topic categories:

Epilepsies, Partial
Epilepsy
Seizures
Central Nervous System Diseases

D 23129
Brain Diseases
Anticonvulsants

Additional relevant MeSH terms:

Epilepsies, Partial
Epilepsy
Therapeutic Uses
Nervous System Diseases
Central Nervous System Diseases

D 23129
Brain Diseases
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on September 10, 2009