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Result Summaries: retigabine

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Study ID
   Phase    Title Summary (Download)
113214 phase 1 An open-label, five-way, partially randomized crossover study to evaluate the regional gastrointestinal absorption of retigabine in healthy volunteers (0 citation(s)) Click here to download result summary.
113215 phase 1 A two part study to assess the pharmacokinetic performance of three retigabine modified release (MR) formulations after single dose and to assess the pharmacokinetics and tolerability of titration with retigabine MR (0 citation(s)) Click here to download result summary.
113287 phase 1 An open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of retigavine given as the Market Image tablet compared to the retigavine clinical trial tablets. (0 citation(s)) Click here to download result summary.
114137 phase 1 An open label, randomized, up-titration study to assess the effect of urine sample handling procedures on the safety results of urine obtained from healthy subjects receiving repeat doses of ezogabine/retigabine. (0 citation(s)) Click here to download result summary.
114552 phase 1 An open label, randomised, repeat dose study to assess the pharmacokinetic performance of five ezogabine/retigabine modified release (MR) formulations at steady state compared to the immediate release (IR) formulation. (0 citation(s)) Click here to download result summary.
115049 n\a Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy (1 citation(s)) Click here to download result summary.
115476 phase 3 Meta-Analysis of VRX-RET-E22-303 and VRX-RET-E22-304: Two Multicenter, Open-Label, Long-Term, Safety, Tolerability and Efficacy Studies of Retigabine in Adult Epilepsy Patients with Partial-onset Seizures (Extensions of Studies VRX-RET-E22-301 and VRX-RET-E22-302) (1 citation(s)) Click here to download result summary.
115860 phase 1 An open-label, randomized, single centre, 4-way crossover study to evaluate the pharmacokinetics of single oral doses of ezogabine/retigabine in healthy adult Taiwanese subjects (0 citation(s)) Click here to download result summary.
116216 phase 1 An interaction study to assess the effect of the ezogabine/retigabine and the main metabolite NAMR on the pharmacokinetics of digoxin in healthy volunteers (0 citation(s)) Click here to download result summary.
3065A1-100 phase 1 Clinical trial to assess safety, tolerability and pharmacokinetics of orally administered Retigabine in healthy male volunteers (0 citation(s)) Click here to download result summary.
3065-A1-101 phase 1 Investigation into the tolerability, safety and steady state kinetics after repeated oral administration for 29 days of D-23129 in healthy volunteers (0 citation(s)) Click here to download result summary.
3065A1-102 phase 1 Ascending multiple dose tolerance study of retigabine in healthy male subjects (0 citation(s)) Click here to download result summary.
3065A1-103 phase 1 Relative Bioavailability of Retigabine (D-23129) from various modified release formulations (TESTS) versus immediate release capsule (REFERENCE) in healthy male volunteers (0 citation(s)) Click here to download result summary.
3065A1-104 phase 1 The effects of a high-fat meal on the pharmacokinetics of two sustained release formulations of retigabine (GKE-841;D-23129) in healthy male subjects (0 citation(s)) Click here to download result summary.
3065A1-105 phase 1 Effect of age and sex on the pharmacokinetics of retigabine (0 citation(s)) Click here to download result summary.
3065A1-106 phase 1 Food Interaction Study of Retigabine in Healthy Volunteers of Both Sexes (0 citation(s)) Click here to download result summary.
3065A1-107 phase 1 A 30-day safety and tolerability study of various titration regimens of retigabine in healthy male subjects (0 citation(s)) Click here to download result summary.
3065A1-108 phase 1 A study of the metabolic pathways and mass balance of orally administered [14C]-labeled Retigabine in healthy male subjects (0 citation(s)) Click here to download result summary.
3065A1-109 phase 1 An open-label, drug interaction study of retigabine and lamotrigine in healthy male subjects (0 citation(s)) Click here to download result summary.
3065A1-110 phase 1 A Comparative Bioavailability study of three oral dose formulations of retigabine in healthy adult subjects (0 citation(s)) Click here to download result summary.
3065A1-112 phase 1 A study of the potential effect of retigabine on the pharmacokinetics of an oral contraceptive containing norgestral and ethinyl estradiol in healthy female subjects (0 citation(s)) Click here to download result summary.
3065A1-113 phase 1 An open label drug interaction study of retigabine and Phenobarbital in healthy male subjects (0 citation(s)) Click here to download result summary.
3065A1-115 phase 1 Pharmacokinetics of Retigabine and its N-Acetylated Metabolite (NAMR) and the Impact on Serum Bilirubin in Subjects with Different Genotypes for UDP-glucuronyl transferase 1A1 (UGT1A1) and N-acetyl transferase (NAT2) (0 citation(s)) Click here to download result summary.
3065A1-117 phase 1 Tolerability of intravenous dose titration of retigabine administered as short time infusion in healthy male volunteers (0 citation(s)) Click here to download result summary.
3065A1-120 phase 1 Relative bioavailability of retigabine (D-23129) from various modified release formulations (TESTS) versus immediate release capsules (REFERENCE) in healthy male volunteers – second study (0 citation(s)) Click here to download result summary.
3065A1-121 phase 1 A study of the effects of blood collection processing on measured retigabine concentrations in healthy male volunteers (0 citation(s)) Click here to download result summary.
3065A1-123 phase 1 Absolute and Relative Bioavailability of Retigabine IR capsules in Healthy Male Subjects (0 citation(s)) Click here to download result summary.
3065A1-200/201 phase 2 Efficacy, Tolerability, Safety and Pharmacokinetics of orally administered D-23129 in patients with partial onset seizures (1 citation(s)) Click here to download result summary.
3065A1-202 phase 2 A Multicenter, Open-Label, Safety, Tolerability, and Preliminary Efficacy Study of GKE-841 (Retigabine, D-23129) Administered as Add-On Therapy to Patients with Epilepsy Currently Receiving Monotherapy with an Established Anticonvulsive Agent (1 citation(s)) Click here to download result summary.
3065A1-205 phase 2/3 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 (1 citation(s)) Click here to download result summary.
3065A1-208 phase 2 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) (1 citation(s)) Click here to download result summary.
3065A1-209 phase 2 An Open-Label, Sequential-Group Feasibility Study to Assess the Tolerability of Rapid Dose Escalation of Retigabine in Epileptic Patients Under Ongoing Presurgical Assessment (1 citation(s)) Click here to download result summary.
3065A1-212 phase 2 A multicenter, open-label, long-term, safety tolerability, and efficacy study of retigabine in adult patients with epilepsy (extension of study 205) (1 citation(s)) Click here to download result summary.
3065A1-214 phase 2 A Randomized, Double-Blind, Parallel-Group, Exploratory Safety and Tolerability Study of 3 Titration Rates of Retigabine (D-23129; GKE-841) Administered as Add-on Therapy in Patients with Refractory Partial Epilepsy (1 citation(s)) Click here to download result summary.
3065A1-216 phase 2 A Multicenter, Open-Label, Long-Term Extension, Safety and Tolerability Study of Retigabine (GKE-841) in Adult Patients with Epilepsy (1 citation(s)) Click here to download result summary.
D-23129-8001/8005/ 8017 phase 2 Long term efficacy and safety of orally administered D-23129 in patients with partial onset seizures (long-term extension of studies 8001 [200] and 8005 [201]) (0 citation(s)) Click here to download result summary.
D-23129-8040 phase 2 Clinical trial to assess tolerability, safety and efficacy of orally administered retigabine in patients with bipolar affective disorders (acute mania). Open pilot study with a sequential group design (0 citation(s)) Click here to download result summary.
VRX-RET-E22-101SR phase 1 Open-Label, Single-Dose, 8-Period Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a 400 mg Dose of Retigabine Sustained-Release Formulations in Seven Dosing Periods Versus a 200 mg Dose of Retigabine Immediate-Release Formulation in One (0 citation(s)) Click here to download result summary.
VRX-RET-E22-103 phase 1 A Double-Blind Randomized Parallel-group Trial to Define the ECG Effects of Retigabine Using a Maximum Tolerated Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Healthy Men and Women: A Thorough ECG Trial (0 citation(s)) Click here to download result summary.
VRX-RET-E22-104 phase 1 Comparative, Randomized, Open-Label, Single-Dose, 2-way Crossover Food Effect, Safety and Tolerability Study of a 400-mg Dose of the Retigabine Market Image Tablet in Healthy Adult Male Subjects (0 citation(s)) Click here to download result summary.
VRX-RET-E22-105 phase 1 Comparative, Randomized, Open-Label, Single-Dose, 2-Way Crossover Bioavailability, Safety and Tolerability Study of a 400 mg Dose of Retigabine Administered as the Clinical Trials Formulation and the Market Image Formulation in Healthy Adult Male Subjects (0 citation(s)) Click here to download result summary.
VRX-RET-E22-106 phase 1 A Pharmacokinetic Interaction Study Evaluating the Effect of Repeated Retigabine Dosing on the Pharmacokinetics of Oral Contraceptives in Healthy Adult Female Volunteers (0 citation(s)) Click here to download result summary.
VRX-RET-E22-107 phase 1 A Randomized, Partially Double-Blind, Four-Way Crossover Study to Determine the Effects of a Single Dose of (1 citation(s)) Click here to download result summary.
VRX-RET-E22-108 phase 1 A Randomized, Double-Blind, Placebo- and Active-Controlled Crossover Study to Evaluate the Abuse Potential (0 citation(s)) Click here to download result summary.
VRX-RET-E22-301 phase 3 A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study to Determine the Efficacy and Safety of Retigabine (1200 mg/day) Used as Adjunctive Therapy in Refractory Epilepsy Patients with Partial-Onset Seizures (2 citation(s)) Click here to download result summary.
VRX-RET-E22-302 phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study - Determine Efficacy and Safety of Two Doses of Retigabine (900 Mg/Day and 600 Mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients with Partial-Onset Seizures (2 citation(s)) Click here to download result summary.
VRX-RET-E22-MR103 phase 1 Open-Label Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Retigabine Following Single and Multiple Dose Administration of Two Different Modified Release Formulations Compared to Single Dose Administration of One Immediate Release Formula (0 citation(s)) Click here to download result summary.