A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vascular Headaches; Migraine
Intervention: topiramate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
Official title: A Comparison Of The Efficacy And Safety Of Topamax® (Topiramate) Tablets Versus Placebo For The Prophylaxis Of Migraine
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Reduction in the frequency of monthly migraine episodes during the entire double-blind treatment phase compared with the pretreatment phase.
Secondary outcome: Percent of patients responding to treatment (>= 50% reduction in average monthly migraine attacks)reduction in number of migraine days/month during treatment; reduction in severity and duration of migraines; incidence of adverse events throughout study.
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 days/month 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).
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Meet the criteria of the International Headache Society for the classification of
migraine with or without aura (migraine symptoms)
- Diagnosis of migraine for at least 12 months prior to start of the study
- Have had an average of 3 to 8 migraine attacks per month for the 3 months prior to the
start of the study
- Ability to recognize migraine headaches and to distinguish them from tension-type
headaches or other types of head pain
- General good health
Exclusion Criteria:
- Patients who previously failed to respond to topiramate therapy for migraine
prevention or who discontinued topiramate due to adverse events
- Patients who had onset of migraine after age 50
- Patients having more than 15 headache-days per month during the 3 months prior to
start of the study, or during the baseline (pretreatment) period
- Patients who have cluster headaches or who have exclusively aura (migraine symptoms)
without headache
- Female patients who are pregnant, nursing, or those not using adequate birth control,
if capable of bearing children
Locations and Contacts
Additional Information
Starting date: October 2000
Ending date: December 2001
Last updated: May 11, 2007
|
