Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210821
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis
Status:
COMPLETED
Status Verified Date:
2010-05
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 purpose of this study is to compare the effectiveness and safety of two treatment regimens in preventing migraines The antidepressant amitriptyline has been used successfully to prevent migraine headaches
Detailed Description:
People who suffer from migraines have many prescription medications to choose from both to treat the migraine and to prevent it from starting However many patients have not had success in finding the drug that helps them best Amitriptyline an antidepressant has been used successfully for many years to prevent migraine headaches This study will compare the effectiveness of amitriptyline with the effectiveness of topiramate an anti-seizure drug in preventing migraines The safety of both drugs will also be assessed The objective of the study is to demonstrate that topiramate will be at least as effective as amitriptyline in preventing migraines During the first 4 weeks of the study topiramate or amitriptyline will be increased by 25 mg per week up to a total dose of 100 mg per day or up to the maximum tolerated dose whichever is less Treatment will continue at 100 mg per day for 22 weeks
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