This trial is active, not recruiting.

Condition migraine
Treatments amitriptyline, topiramate
Sponsor Rambam Health Care Campus
Start date July 2008
End date December 2010
Trial size 100 participants
Trial identifier NCT01161017, Migraine06CTIL


Mechanism-based choice of therapy for pain:

Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
Initial dose of 12.5mg will be given for 2 days. Then, daily 25mg will be taken for additional 8 weeks
(Active Comparator)
For the first 5 days of treatment 25mg is prescribed and should be ingested in one evening dose. For another 5 days, 25g dose should be taken twice a day (morning and evening). For the next 5 days, morning dose will be 25mg; evening dose will be 50mg. For the remaining 6 weeks of treatment, a dose of 50mg twice a day will be advised

Primary Outcomes

Therapeutic response to the analgesic drugs
time frame: 2 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - female and male migraine patients with a number of month attacks ≥ 4, - age 18-75, - without any other chronic pain. Exclusion Criteria: - any migraine preventive treatment for last 6 month & psychiatric, - language or cognitive dysfunction precluding use of psychophysics.

Additional Information

Official title Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by Rambam Health Care Campus.