Last updated: 11/07/2018 14:16:57
A multicenter, open-label, long-term, safety tolerability, and efficacy study of GKE-841 (retigabine D-23129) in adult patients with epilepsy (extension of study 202)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A multicenter, open-label, long-term, safety tolerability, and efficacy study of GKE-841 (retigabine D-23129) in adult patients with epilepsy (extension of study 202)
Trial description: A multicenter, open-label, long-term, safety tolerability, and efficacy study of GKE-841 (retigabine D-23129) in adult patients with epilepsy (extension of study 202)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Neil Brickel, Paul Gandhi, Kevan VanLandingham, Janet Hammond, Sarah DeRossett. The urinary safety profile and secondary renal effects of retigabine (ezogabine): A first-in-class antiepileptic drug that targets KCNQ (Kv7) potassium channels . Epilepsia. 2012;53(4):606-612.
Rajesh Sachdeo, Arnaud Partiot, Victor Biton, William E Rosenfeld, Virinder Nohria, Debra Tompson, Sarah DeRossett, Roger Porter. A novel design for a dose finding, safety, and drug interaction study of an antiepileptic drug (retigabine) in early clinical development. Int J Clin Pharmacol Ther. 2014;52(6):509-518.
Medical condition
Seizures
Product
retigabine, ezogabine
Collaborators
Not applicable
Study date(s)
N/A to January 2003
Type
Not applicable
Phase
2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-29-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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