Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310388
Status:
TERMINATED
Last Update Posted:
2018-11-15
First Post:
2006-03-30
Brief Title:
Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial 115097
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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-E22-302
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No longer any benefit in collecting data since retigabine has been withdrawn from market
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 3 trial is an open-label extension study of the placebo-controlled double-blind VRX-RET-E22-302 trial Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mgday of retigabine as an adjunct therapy to their current antiepileptic drugs AEDs or vagal nerve stimulation Treatment will be continued until the subject withdraws from the study or until the program is discontinued Patients will be recruited from 55-60 sites in Europe Israel Australia and South Africa The primary objective of the 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 double-blind Study VRX-RET-E22-302 Secondary objectives are to evaluate efficacy of long-term treatment with retigabine and patient quality of life and to evaluate whether retinal pigmentation unexplained vision loss pigmentation of non-retinal ocular tissue and discoloration of nails lips skin or mucosa change over time after discontinuation of retigabine
Detailed Description:
This Phase 3 trial is an open-label extension study of the placebo-controlled double-blind VRX-RET-E22-302 trial Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mgday 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 55-60 sites in Europe Israel Australia and South Africa 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RTG115097 | OTHER | GlaxoSmithKline | None |
| EUDRACT No 2006-000956-42 | None | None | None |