Phase 3
N=306
Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
Seizures
Bottom Line
View on ClinicalTrials.gov: NCT00232596 ↗Enrolled (actual)
306
Serious AEs
7.3%
Results posted
Oct 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) — -17.5; -44.3 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
- Jan 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) |
-17.5; -44.3 | <0.001 sig |
| PRIMARY Number of Participants Who Were Responders and Non-responders in the Maintenance Phase |
31; 66; 106; 53 | <0.001 sig |
| SECONDARY Number of Participants Who Were Responders and Non-responders in the DB Phase |
27; 68; 125; 85 | — |
| SECONDARY Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase |
-18.9; -54.5 | — |
| 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 |
6; 27; 21; 41; 37; 20 | — |
| SECONDARY Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories |
0; 12; 5; 11; 4; 10 | — |
| SECONDARY Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase |
13; 37; 18; 29; 65; 33 | — |
| 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 |
20; 4; 21; 16; 96; 99 | — |
| 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 |
33; 42; 12; 17; 7; 12 | — |
| SECONDARY Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases) |
0; 3; 150; 148 | — |
| SECONDARY Number of Participants Who Were Seizure-free During the Maintenance Phase |
2; 9; 135; 110 | — |
| SECONDARY Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases) |
77.3; 84.1 | — |
| SECONDARY Percentage of Seizure-free Days During the Maintenance Phase |
78.2; 86.9 | — |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase |
3.2; 2.7 | — |
| SECONDARY Patient Global Impression (PGI) Score at the End of the Maintenance Phase |
2.9; 2.9 | — |
| SECONDARY Quality of Life (QOL) Assessed by QOL in Epilepsy-Problems Questionnaire (QOLIE-31-P) at Baseline (Week 0) and Weeks 6, 10, and 18 |
52.6; 55.6; 55.2; 55.7; 57.9; 56.2 | — |
| SECONDARY Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm) |
3; 3; 4; 2; 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) |
1; 2; 9; 0; 2; 2 | — |
| SECONDARY Change From Baseline in Post-void Residual Urine Volume at Weeks 10 and 18 of the DB Treatment Phase |
-1.0; 0.0; -3.0; 0.0 | — |
| SECONDARY Number of Participants With a >=7% Increase in Body Weight During Weeks 2, 4, and 6 of theTitration Phase and Weeks 7, 8, 10, 14, and 18 of the Maintenance Phase |
0; 5; 0; 5; 1; 6 | — |
Summary
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 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 (NCT00232596). 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.