A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients W… (NCT00603473) | Clinical Trial Compass
CompletedPhase 3
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Japan92 participantsStarted 2008-01
Plain-language summary
Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
Who can participate
Age range3 Years – 15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures
Timeframe: 12 weeks
Trial details
NCT IDNCT00603473
SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.