Phase 3 Completed N=89 Treatment

A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

Epilepsies, Partial

Source: ClinicalTrials.gov NCT00603473 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

Feb 2011

Primary outcomePrimary: Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures — -0.158 ratio

Summary

Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.