Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 3

Conditions: Seizures; Epilepsy; Partial Seizure Disorder

Treatments: Drug: placebo; Drug: topiramate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113815

CR002233

Details and patient eligibility

About

The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).

Full description

This is a world wide, multicenter, randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety and efficacy of 3 target doses (5, 15, and 25 mg/kg/day) of topiramate compared with placebo as an adjunct therapy in infants with refractory partial onset seizures (POS). There are 4 phases to the study, a screening phase of 3 days, a double blind treatment phase of 20 days, a one year open label extension phase and a posttreatment (taper and withdrawal) phase. The oral liquid formulation will also be assessed during this study, as it is investigational, unlike the marketed sprinkle formulation. 5, 15, 25 mg/kg/day of topriramate sprinkle and oral liquid formulation will be administered during the four phases of the study.

Enrollment: 118 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1-24 months, inclusive
• Concurrent 1 or 2 antiepileptic drugs
• Receiving regular enteral feedings
• Weigh between 3.5 and 15 kg
• Clinical or EEG evidence of simple or complex POS

Exclusion criteria

• Exclusively breast fed and cannot take medicine by mouth
• Surgically implanted and functioning vagus nerve stimulator
• Renal stones
• Medically uncontrolled illnesses or conditions
• Infantile seizures as a result of a correctable medical condition
• Progressive neurologic disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 4 patient groups

003

Experimental group

Description:

topiramate 25 mg/kg/day

Treatment:

Drug: topiramate

Drug: topiramate

Drug: topiramate

002

Experimental group

Description:

topiramate 15 mg/kg/day

Treatment:

Drug: topiramate

Drug: topiramate

Drug: topiramate

001

Experimental group

Description:

topiramate 5 mg/kg/day

Treatment:

Drug: topiramate

Drug: topiramate

Drug: topiramate

004

Experimental group

Description:

placebo placebo

Treatment:

Drug: placebo