Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210535
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-13
Brief Title:
A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine Attacks in Children
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Topiramate for the Prophylaxis of Migraine in Pediatric Subjects 12 to 17 Years of Age
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the prevention of migraine attacks in children 12 to 17 years of age
Detailed Description:
This is an outpatient randomized double-blind placebo-controlled study to evaluate the effectiveness of 2 dosages of topiramate 50 and 100 milligramsday compared with placebo in the prevention of migraine attacks in children 12 to 17 years of age The study is composed of 3 phases pretreatment double-blind treatment for 4 months 16 weeks and posttreatment During the study patients will maintain headache and medication records to document the following occurrence and duration of headaches severity of headache pain whether or not the headache is pulsating or aggravated by physical activity associated symptoms such as nausea vomiting photophobia phonophobia abdominal pain and medication taken to relieve headache pain or symptoms Assessment of efficacy include the percent reduction in the frequency of monthly migraine attacks over the last 12 weeks of the double-blind treatment phase compared with prospective BL period In addition the percent reduction in a average monthly migraine days b average monthly headache days and c monthly migraine rate over the last 12 weeks of the double-blind treatment phase compared with the pretreatment phase will be assessed Safety assessments include the incidence of adverse events measurement of vital signs pulse blood pressure oral temperature results of pregnancy tests physical and neurologic examinations clinical laboratory tests hematology biochemistry and urinalysis and monitoring for visual or ocular disturbances heat intolerance renal or urinary disturbance depression and rash The study hypothesis is that the percent reduction in frequency of monthly 28-day migraine attacks using the 48-hour rule from the prospective baseline period pretreatment phase to the last 12 weeks of the double-blind phase will be significantly better for the topiramate groups than for the placebo group Topiramate tablets 25 milligrams or placebo beginning at 25mg once daily Week 1 increasing to twice daily total of 50mg or 100mg Week 4 Maximum dosage of topiramate or placebo continues for next 12 weeks Dosage may be reduced once at investigators discretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None