Phase 3
N=539
Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
Seizures
Bottom Line
View on ClinicalTrials.gov: NCT00235755 ↗Enrolled (actual)
539
Serious AEs
4.7%
Results posted
Nov 2011
Primary outcome: Primary: Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases) — -15.9; -39.9; -27.9 percent change in seizure frequency — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Retigabine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases) |
-15.9; -39.9; -27.9 | <0.001 sig |
| PRIMARY Number of Participants Classified as Responders and Non-responders During the Maintenance Phase |
31; 70; 61; 133; 79; 97 | <0.001 sig |
| SECONDARY Number of Participants Who Were Responders and Non-responders During the DB Phase |
31; 57; 70; 148; 124; 108 | — |
| SECONDARY Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase |
-17.4; -35.3; -44.3 | — |
| SECONDARY Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories |
12; 16; 27; 19; 41; 43 | — |
| SECONDARY Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories |
3; 5; 11; 4; 8; 14 | — |
| SECONDARY Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase |
11; 27; 30; 20; 34; 40 | — |
| SECONDARY Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase |
28; 14; 11; 22; 23; 19 | — |
| SECONDARY Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline |
9; 8; 12; 6; 5; 9 | — |
| SECONDARY Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases) |
2; 0; 7; 174; 179; 168 | — |
| SECONDARY Number of Participants Who Were Seizure-free During the Maintenance Phase |
2; 5; 7; 162; 153; 142 | — |
| SECONDARY Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases) |
77.8; 79.5; 82.1 | — |
| SECONDARY Percentage of Seizure-free Days During the Maintenance Phase |
78.1; 81.6; 84.5 | — |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase |
3.2; 2.9; 2.9 | — |
| SECONDARY Patient Global Impression (PGI) Score at the End of the Maintenance Phase |
3.3; 2.9; 3.0 | — |
| SECONDARY Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) at BL (Week 0) and Weeks 4, 8, and 16 |
53.3; 56.0; 52.1; 55.4; 57.3; 52.7 | — |
| SECONDARY Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm) |
3; 2; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm) |
0; 3; 4; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Post-void Residual Urine Volume at Weeks 8 and 16 of the Maintenance Phase |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With a >=7% Increase in Body Weight During Weeks 2 and 4 of theTitration Phase and Weeks 6, 8, 12, and 16 of the Maintenance Phase |
0; 3; 3; 0; 7; 8 | — |
Summary
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization
- 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase
- Currently treated with up to three established AEDs
- Vagal Nerve Stimulator may be included
Exclusion Criteria
- Existing medical or psychiatric condition which could affect patient's health or compromise ability to participate in the study
- Clinically significant abnormalities on physical exam, vital signs, ECG, or liver function tests
- Impaired renal function (creatinine clearance less than 50 mL/minute)
- Evidence of progressive central nervous disease, lesion, or encephalopathy
- History of primary generalized seizures
- History of clustering or flurries or status epilepticus within 12 months of study entry
Data sourced from ClinicalTrials.gov (NCT00235755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.