Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00253175
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2005-11-10
Brief Title:
A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Comparison Of The Efficacy And Safety Of Topamax Topiramate Tablets Versus Placebo For The Prophylaxis Of Migraine
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 primary purpose of this study is to evaluate the effectiveness and safety of topiramate an epilepsy medication compared with placebo in the prevention of migraine
Detailed Description:
Topiramate is a medication that is widely used for the treatment of adult and pediatric patients with seizures and has been shown in preliminary studies to be effective for migraine prevention in adults This is an outpatient randomized double-blind placebo-controlled study to confirm preliminary studies of the effectiveness of topiramate in the prevention of migraine attacks The study is composed of 4 phases pretreatment double-blind treatment for 20 weeks a blinded transition and an open-label extension During the pretreatment phase patients discontinue all medication for migraine prevention and keep a daily record of headache information in a diary Patients with 3 to 8 migraines but not more than 15 headache days during the pretreatment phase continue in the double-blind treatment phase In the 20-week double-blind treatment phase oral topiramate tablets or placebo are taken daily beginning at 25 mg once daily for 1 week increasing to twice daily doses of up to a maximum of 8 tablets 200 mg per day during the 8-week titration period and maintained at that dose during the 12-week maintenance period Patients who successfully complete the double-blind therapy phase may continue in an open-label extension 32 weeks during which the study medication topiramate or placebo will be decreased and simultaneously topiramate open-label will be administered at increasing doses During the study patients will maintain headache and medication records to document the following occurrence and duration of headaches severity of headache pain associated symptoms such as nausea vomiting photophobia avoidance and dread of light phonophobia fear of sound and medication taken to relieve headache pain or symptoms The primary measure of effectiveness is the percent reduction in the frequency of monthly migraine episodes during the entire double-blind treatment phase compared with the pretreatment phase Other assessments of effectiveness include the percent of patients responding to treatment 50 reduction in average monthly migraine attacks during the double-blind treatment phase compared with the pretreatment phase the reduction in number of migraine daysmonth during treatment and the reduction in severity and duration of migraines during treatment Safety assessments include the incidence of adverse events throughout the study and measurement of vital signs pulse blood pressure body weight physical examinations and clinical laboratory tests hematology biochemistry and urinalysis at specified intervals The study hypothesis is that the decrease in the mean monthly migraine rate is greater in the topiramate group than in the placebo group
Oral topiramate tablets 25 mg or placebo tablets beginning at 25 mg once daily for 1 week increasing to twice daily doses of up to a maximum of 8 tablets 200 mg during the 8-week titration period and maintained at that dose during the 12-week maintenance period 20 weeks total duration
Oral topiramate tablets 25 mg or placebo tablets beginning at 25 mg once daily for 1 week increasing to twice daily doses of up to a maximum of 8 tablets 200 mg during the 8-week titration period and maintained at that dose during the 12-week maintenance period 20 weeks total duration
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