Phase 3 N=65 Treatment

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

Epilepsies, Partial

Bottom Line

View on ClinicalTrials.gov: NCT00620555 ↗

Enrolled (actual)

Serious AEs

3.1%

Results posted

Dec 2011

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) — 58; 13; 2; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: gabapentin (Drug)
Age: Pediatric, Adult, Older Adult · 3+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Dec 2010

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	—

Summary

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

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

View full record on ClinicalTrials.gov →

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.