Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00237302
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-10-07
Brief Title:
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Preventing Migraine Headaches in Children
Sponsor:
Ortho-McNeil Neurologics Inc
Organization:
Ortho-McNeil Neurologics Inc
Study Overview
Official Title:
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Migraine in Pediatric Subjects
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children
Detailed Description:
Pediatric migraine headache is a common cause of severe recurring headaches in children especially children between the ages of 5 and 15 years These headaches can be disabling and tend to interfere with a childs daily activities such as going to school or playing with friends Because pediatric migraine children tend to be misdiagnosed they are often not treated effectively Topiramate an anti-seizure medication has been shown to prevent migraines in adults and it has been approved to treat seizures in children as young as 2 years of age as add-on treatment used with another drug and also can be used alone monotherapy in children as young as 10 years old Since topiramate has already been studied in children information about its safety in children is available In this study children with migraine headaches will be identified It is not necessary for the child to have the migraine aura having blurry vision seeing flashing lights to be included in this study This is a randomized double-blind placebo-controlled study of Topiramate or placebo given for 4 to 5 months An optional 3-month open-label extension topiramate only no placebo will follow The objective of the study is to demonstrate that topiramate is effective and safe when used to prevent migraine headaches with or without aura in children Safety will be assessed throughout the study
Topiramate sprinkle capsules or placebo starting at 15 milligrams per day for 1st week increased to 30 milligrams per day for week 2 increased to 50 milligrams in tablets per day in week 3 then adjusted as needed to 2 to 3 milligramskilogramday for the rest of study 140 days total
Topiramate sprinkle capsules or placebo starting at 15 milligrams per day for 1st week increased to 30 milligrams per day for week 2 increased to 50 milligrams in tablets per day in week 3 then adjusted as needed to 2 to 3 milligramskilogramday for the rest of study 140 days total
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