Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial
Status: | Completed |
---|---|
Conditions: | Neurology, Epilepsy |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/17/2018 |
Start Date: | May 1, 2006 |
End Date: | March 15, 2017 |
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)
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.
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.
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.
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.
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.
We found this trial at
31
sites
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Medical City Dallas Hospital If you have concerns for your health, that of a family...
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University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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