Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210860
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
An Open Label Extension of a Study Comparing Topiramate and Amitriptyline in Migraine Prevention
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open-label Study of the Safety and Efficacy of Topiramate for Migraine Prophylaxis Extension Study to CAPSS-277
Status:
COMPLETED
Status Verified Date:
2010-04
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 assess the long-term safety and effectiveness of topiramate for the prevention of migraine headaches in adults Topiramate has been approved to prevent migraine headaches in adults
Detailed Description:
Migraine headaches can be disabling and can interfere with work and a persons quality of life Preventing these headaches before they start is the best option Topiramate an anti-seizure medication has been shown to help prevent migraine headaches from occurring This is an open-label study that is an extension of a previous study CAPSS-277 comparing topiramate and amitriptyline in migraine prevention It includes patients who completed the previous study and elected to enter open label treatment with topiramate The study will involve a 4-week Blinded Transition Phase during which patients will be titrated up to a daily topiramate dose of 100 milligrams or the maximum tolerated dose whichever is less Then there will be a 12-week Open-Label Maintenance Phase during which the topiramate dose may be adjusted according to effectiveness and tolerance but not to exceed a daily dose of 400 milligrams While on topiramate patients will record daily entries in their headache records Patients will be asked questions to help assess their quality of life Patients will also have physical examinations and laboratory tests performed during the study The objective of this study is to evaluate the long-term safety and effectiveness of topiramate for the prevention of migraine headaches
Topiramate oral tablets 25 milligrams per tablet will be given in the morning and evening to a dose not to exceed 400 milligrams per day or to the maximum tolerated dose whichever is less
Topiramate oral tablets 25 milligrams per tablet will be given in the morning and evening to a dose not to exceed 400 milligrams per day or to the maximum tolerated dose whichever is less
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