Phase 3
N=89
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Epilepsies, Partial
Bottom Line
View on ClinicalTrials.gov: NCT00603473 ↗Enrolled (actual)
89
Serious AEs
1.1%
Results posted
Feb 2011
Primary outcome: Primary: Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures — -0.158 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- gabapentin (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures |
-0.158 | — |
| SECONDARY Responder Rate |
19.8 | — |
| SECONDARY Percent Change in Seizure Frequency (PCH) |
-24.4 | — |
Summary
Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
Eligibility Criteria
Inclusion Criteria
- Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15 years old or less at the baseline visit
- Seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the International League Against Epilepsy)
- Have not been able to achieve adequate seizure control with antiepileptic drugs
Exclusion Criteria
- Seizures related to drugs or acute medical illness
- History of any serious medical or psychiatric disorder
- Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be progressive
Data sourced from ClinicalTrials.gov (NCT00603473). 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.