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

Epilepsy Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113815
• Other study ID #: CR002233
• Status: Completed
• Phase: Phase 3
• First received: June 10, 2005
• Last updated: March 25, 2014
• Start date: May 2005
• Est. completion date: November 2007

Study information

• Verified date: March 2014
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: November 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Partial Seizure Disorder
• Seizures

Intervention

Drug:
• topiramate
15 mg/kg/day
• topiramate
5 mg/kg/day
• topiramate
25 mg/kg/day
• placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Chile,  Finland,  France,  Hungary,  India,  Israel,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Russian Federation,  South Africa,  Spain,  Taiwan,  Thailand,  Ukraine, 

References & Publications (1)

Novotny E, Renfroe B, Yardi N, Nordli D, Ness S, Wang S, Weber T, Kurland CL, Yuen E, Eerdekens M, Venkatraman L, Nye JS, Ford L. Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures. Neurology. 2010 Mar 2;74(9):71 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader		Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader	No
Secondary	Percent treatment responders >=50% reduction seizure rate. ·Percentage change in seizure rate recorded on subject take-home records. Percentage change in seizure rates for all seizure types recorded on VEEG.		Baseline to endpoint of double blind phase	No

External Links

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