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

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Completed
• CT.gov ID: NCT01161017
• Collaborator: (none)
• Enrollment: 67
• Location: 1
• Arms: 2
• Actual Duration (Months): 70
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Mechanism-based choice of therapy for pain:

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

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Amitriptyline; Drug: Topiramate	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?
• Actual Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Amitriptyline. Amitriptyline	Drug: Amitriptyline; Initial dose of 12.5mg will be given for 2 days. Then, daily 25mg will be taken for additional 8 weeks
Active Comparator: 2 Topiramate Topiramate	Drug: 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

Outcome Measures

Primary Outcome Measures

1. Therapeutic response to the analgesic drugs [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam Medical Center	Haifa		Israel

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: d_yarnitsky, Head of Neurology Department, Rambam Health Care Campus
• ClinicalTrials.gov Identifier: NCT01161017
• Other Study ID Numbers: Migraine06CTIL
• First Posted: Jul 13, 2010
• Last Update Posted: Oct 11, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by d_yarnitsky, Head of Neurology Department, Rambam Health Care Campus: migraine patients
• Additional relevant MeSH terms: Migraine Disorders; Topiramate; Amitriptyline

Study Results

No Results Posted as of Oct 11, 2017