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NCT01161017 Clinical Trial

Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?

Migraine Clinical Trial

Official title:
Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01161017
Other study ID # Migraine06CTIL
Secondary ID
Status Completed
Phase N/A
First received July 10, 2010
Last updated October 10, 2017
Start date July 2008
Est. completion date May 2014

Study information
Verified date October 2017
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Mechanism-based choice of therapy for pain:

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

Recruitment information / eligibility
Status Completed
Enrollment 67
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amitriptyline
Initial dose of 12.5mg will be given for 2 days. Then, daily 25mg will be taken for additional 8 weeks
• Topiramate
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

Locations
Country Name City State
Israel Rambam Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Therapeutic response to the analgesic drugs 2 months
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