Last updated: 06/24/2020 18:10:09
A Randomized, Double-blind, Placebo-controlled, Parallel group, Multicenter, Dose-ranging, Efficacy and Safety Study of Retigabine (D-23129; GKE-841) Administered as Add-on Therapy in Patients With Partial Epilepsy
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 Randomized, Double-blind, Placebo-controlled, Parallel group, Multicenter, Dose-ranging, Efficacy and Safety Study of Retigabine (D-23129; GKE-841) Administered as Add-on Therapy in Patients With Partial Epilepsy
Trial description: A Randomized, Double-blind, Placebo-controlled, Parallel group, Multicenter, Dose-ranging, Efficacy and Safety Study of Retigabine (D-23129; GKE-841) Administered as Add-on Therapy in Patients With Partial Epilepsy
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:
Debra J. Tompson and Christopher S. Crean. Clinical Pharmacokinetics of Retigabine/Ezogabine. Curr Clin Pharmacol. 2013;8(4):319-331.
Debra J. Tompson and Christopher S. Crean. The Interaction Potential of Retigabine (Ezogabine) with other Antiepileptic Drugs . Curr Clin Pharmacol. 2014;9(2):148-56.
Debra J. Tompson, Christopher S. Crean, Russell Reeve, N. Seth Berry. Efficacy and Tolerability Exposure–Response Relationship of Retigabine (Ezogabine) Immediate-Release Tablets in Patients with Partial-Onset Seizures. Clin Ther. 2013;35(8):1174-1185.e4.
Martin J Brodie, Jacqueline A French, Susan McDonald, Wen-Jene Lee, Bryan Adams, Andrew Scott, Virinder Nohria, Sarah DeRossettu. Adjunctive Use of Retigabine with either Traditional Sodium Channel Blocker Antiepileptic Drugs (AEDs) or AEDs with other Mechanisms of Action: Evaluation of Safety, Tolerability and Efficacy. Epilepsy Res. 2014;
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.
R. J. Porter, D. E. Burdette, A. Gil-Nagel, S. T. Hall, R. White, S. Shaikh, S. E. DeRossett . Retigabine as adjunctive therapy in adults with partial-onset epilepsy: Integrated analysis of three pivotal controlled trials. Epilepsy Res. 2012;101:103-112.
Medical condition
Seizures
Product
retigabine, ezogabine
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Interventional
Phase
2/3
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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
Additional information
Not applicable
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Access to clinical trial data by researchers
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