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Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches

A Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00210821
Enrollment
347
Registered
2005-09-21
Start date
2004-02-29
Completion date
2005-11-30
Last updated
2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Migraine

Keywords

migraine, headache, analgesics, prophylaxis, prevention

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.

Interventions

DRUGtopiramate

Sponsors

Ortho-McNeil Neurologics, Inc.
CollaboratorINDUSTRY
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Migraine headache for at least 6 months, with 3 to 12 headaches a month for the previous 3 months * no more than 15 headache days in the previous month before study start * no heart rhythm problems or neurologic problems * women must not be pregnant and must use birth control

Exclusion criteria

* Cannot have failed at least 2 previous trials of migraine prevention drugs * cannot have failed a previous trial of topiramate or amitriptyline * no cluster headaches * no migraine with aura without headache * no pain that is worse than the migraine pain

Design outcomes

Primary

MeasureTime frame
Change from baseline in the average monthly migraine episode rate.

Secondary

MeasureTime frame
Change in average monthly rate of days with migraine headache; change in average monthly rate of headache (migraine & non-migraine) days; change in average monthly rate of acute abortive medications; weight changes; quality of life assessments

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026