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Birmingham, Alabama

  • Seizures

Purpose:

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


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

CR002233


NCT ID:

NCT00113815


Secondary ID:


Study Acronym:


Brief Title:

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


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 Ag


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

1 Month


Maximum Age:

24 Months


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

118


Enrollment Type:

Actual


Overall Contact Information

Official Name:Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Dates

Start Date:May 2005
Completion Date:November 2007
Completion Type:Actual
Primary Completion Date:June 2007
Primary Completion Type:Actual
Verification Date:March 2014
Last Changed Date:March 25, 2014
First Received Date:June 10, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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.
Time Frame:Baseline to endpoint of double blind phase
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Time Frame:Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 2
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:topiramate
Description:15 mg/kg/day
Arm Name:002
Intervention Type:Drug
Name:topiramate
Description:5 mg/kg/day
Arm Name:001
Intervention Type:Drug
Name:topiramate
Description:25 mg/kg/day
Arm Name:003
Intervention Type:Drug
Name:placebo
Description:placebo
Arm Name:004

Study Arms

Study Arm Type:Experimental
Arm Name:003
Description:topiramate 25 mg/kg/day
Study Arm Type:Experimental
Arm Name:002
Description:topiramate 15 mg/kg/day
Study Arm Type:Experimental
Arm Name:001
Description:topiramate 5 mg/kg/day
Study Arm Type:Experimental
Arm Name:004
Description:placebo placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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):714-20. doi: 10.1212/WNL.0b013e3181d1cd4c. Epub 2010 Jan 20.
PMID:20089937

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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