Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261469
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-12-02
Brief Title:
An Open-label Study to Evaluate Topiramate Therapy in Migraine Patients and Its Effects on Subject Responsiveness to Migraine Treatment With Triptans
Sponsor:
Janssen-Ortho Inc Canada
Organization:
Janssen-Ortho Inc Canada
Study Overview
Official Title:
Efficacy of Topiramate Prophylaxis as add-on to Triptan Therapy for Migraine
Status:
COMPLETED
Status Verified Date:
2011-01
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 evaluate whether prophylactic use of topiramate preventative use before a migraine attack enhances the effectiveness of migraine treatment with triptans
Detailed Description:
The objective of this pilot study is to determine if patients with migraine are more responsive to triptans taken for symptomatic headache treatment while on topiramate prophylactic therapy as compared to a baseline period without prophylaxis The trial is an open-label design with migraine patients receiving topiramate prophylactically twice a day maximum of 200 mgday for 16 weeks following a 6-week Prospective Baseline Period
During the first week of the treatment phase subjects will begin on a once-daily dose of 25 mg of topiramate at night and remain on that dose for two weeks Thereafter the daily dose will be increased by 25 mg with twice-daily dosing If in the investigators judgement further dosage increases beyond 100 mgday are indicated the daily dose will be increased weekly by 25 mg to a daily dose of 150 mg The daily dose may be increased to a maximum daily dose of 200 mg if the subject is tolerating the higher doses
Subjects keep a headache diary in which the following information is recorded time of onset of headache and indication of type of headache time headache stops any symptomatic treatment taken time that tiptan medication is taken headache intensity at the time the triptan is taken 30 minutes one hour and two hours post dose and the presence of nausea at the time the triptan is taken 30 minutes on hour and 2 hours post dose The primary measure of triptan responsiveness is the proportion of triptan treated migraine attacks that were pain-free at two hours after triptan treatment
Safety evaluations during the study include the collection of adverse events laboratory assessments including hematology chemistry and urinalysis and vital signs blood pressure and pulse The hypothesis is that topiramate prophylaxis will increase the responsiveness of migraine attacks to triptan therapy as measured by the proportion of attacks that are pain-free two hours after triptan therapy Subjects will begin week 1 of the Topiramate Treatment phase with 25 mg topiramate at night Thereafter the dose of topiramate will be increased by 25 mg every second week ie week 3 50 mg week 5 75 mg week 7 100 mg If in the investigators judgment further dosage increases are indicated the dose can be increased as follows week 9 125 mg week 10 150 mg week 11 175 mg week 12 200 mgsThe dose may be increased weekly after week 10 if the patient is tolerating the higher
During the first week of the treatment phase subjects will begin on a once-daily dose of 25 mg of topiramate at night and remain on that dose for two weeks Thereafter the daily dose will be increased by 25 mg with twice-daily dosing If in the investigators judgement further dosage increases beyond 100 mgday are indicated the daily dose will be increased weekly by 25 mg to a daily dose of 150 mg The daily dose may be increased to a maximum daily dose of 200 mg if the subject is tolerating the higher doses
Subjects keep a headache diary in which the following information is recorded time of onset of headache and indication of type of headache time headache stops any symptomatic treatment taken time that tiptan medication is taken headache intensity at the time the triptan is taken 30 minutes one hour and two hours post dose and the presence of nausea at the time the triptan is taken 30 minutes on hour and 2 hours post dose The primary measure of triptan responsiveness is the proportion of triptan treated migraine attacks that were pain-free at two hours after triptan treatment
Safety evaluations during the study include the collection of adverse events laboratory assessments including hematology chemistry and urinalysis and vital signs blood pressure and pulse The hypothesis is that topiramate prophylaxis will increase the responsiveness of migraine attacks to triptan therapy as measured by the proportion of attacks that are pain-free two hours after triptan therapy Subjects will begin week 1 of the Topiramate Treatment phase with 25 mg topiramate at night Thereafter the dose of topiramate will be increased by 25 mg every second week ie week 3 50 mg week 5 75 mg week 7 100 mg If in the investigators judgment further dosage increases are indicated the dose can be increased as follows week 9 125 mg week 10 150 mg week 11 175 mg week 12 200 mgsThe dose may be increased weekly after week 10 if the patient is tolerating the higher
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