Phase 3
Completed N=65
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Epilepsies, Partial
Source: ClinicalTrials.gov NCT00620555 ↗
Enrolled (actual)
65
Serious AEs
3.1%
Results posted
Dec 2011
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) — 58; 13; 2; 0 Participants
Summary
Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) |
58; 13; 2; 0; 1; 0 | — |
| SECONDARY Response Ratio |
-0.263; -0.256; -0.300; -0.280; -0.327 | — |
| SECONDARY Responder Rate |
35.4; 40.0; 39.7; 40.7; 46.8 | — |
| SECONDARY Percent Change in Seizure Frequency |
-34.2; -33.0; -42.0; -41.6; -49.2 | — |
Eligibility Criteria
Inclusion Criteria
- Completion of study A9451162 (NCT00603473)
Exclusion Criteria
- Seizures related to drugs or acute medical illness
- History of any serious medical or psychiatric disorder
Data sourced from ClinicalTrials.gov (NCT00620555). 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. Informational only — not medical advice.