Clinical trial NCT00113815: 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 Age) With Refractory Partial-Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Seizure Disorder
Epilepsy
Seizures
Keywords: Partial seizure disorder
Topiramate
Epilepsy
Infants
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2005-06-13
Enrollment: 118
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
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
timeFrame: 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
Secondary outcomes:
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.
timeFrame: Baseline to endpoint of double blind phase
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Wilmington
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Loxahatchee
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Dearborn
country: United States
state: Michigan
city: Saint Paul
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Cherry Hill
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Danville
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Rio Negro
country: Argentina
city: Santa Fe
country: Argentina
city: Heidelberg West
country: Australia
city: Melbourne
country: Australia
city: Subiaco
country: Australia
city: Antwerpen
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Pulderbos
country: Belgium
city: St. John'S
country: Canada
state: Newfoundland and Labrador
city: Saskatoon
country: Canada
state: Saskatchewan
city: Chile
country: Chile
city: Santiago
country: Chile
city: Helsinki
country: Finland
city: Tampere
country: Finland
city: Bordeaux Cedex
country: France
city: Lille
country: France
city: Tours Cedex 9
country: France
city: Budapest
country: Hungary
city: Chennai
country: India
city: Hyderabad Gpo
country: India
city: Kochi Ho
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: Pune
country: India
city: Petah Tikva
country: Israel
city: Seoul
country: Korea, Republic of
city: Monterrey
country: Mexico
city: San Luis Potosi
country: Mexico
city: Heeze
country: Netherlands
city: Wellington
country: New Zealand
city: Bergen
country: Norway
city: Gdansk
country: Poland
city: Warszawa N/A
country: Poland
city: Ekaterinburg Siberia
country: Russian Federation
city: Moscow
country: Russian Federation
city: Omsk Siberia
country: Russian Federation
city: Samara
country: Russian Federation
city: Cape Town Wc
country: South Africa
city: Madrid
country: Spain
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Chiangmai
country: Thailand
city: Donetsk
country: Ukraine
city: Kiev
country: Ukraine
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
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.
citation: Ness S, Todd MJ, Wang S, Eerdekens M, Nye JS, Ford L. Adaptive behavior outcomes in infants treated with adjunctive topiramate. Pediatr Neurol. 2012 Jun;46(6):350-8. doi: 10.1016/j.pediatrneurol.2012.02.028.
citation: Puri V, Ness S, Sattaluri SJ, Wang S, Todd M, Yuen E, Eerdekens M, Nye JS, Manitpisitkul P, Shalayda K, Ford L. Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures. J Child Neurol. 2011 Oct;26(10):1271-83. doi: 10.1177/0883073811406982. Epub 2011 Jun 14.