Back to resultsMechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Amitriptyline
Topiramate
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring migraine patients
Eligibility Criteria
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.
Sites / Locations
- Rambam Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1 Amitriptyline.
2 Topiramate
Arm Description
Amitriptyline
Topiramate
Outcomes
Primary Outcome Measures
Therapeutic response to the analgesic drugs
Secondary Outcome Measures
Full Information
NCT ID
NCT01161017
First Posted
July 10, 2010
Last Updated
October 10, 2017
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT01161017
Brief Title
Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?
Official Title
Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mechanism-based choice of therapy for pain:
Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Amitriptyline.
Arm Type
Active Comparator
Arm Description
Amitriptyline
Arm Title
2 Topiramate
Arm Type
Active Comparator
Arm Description
Topiramate
Intervention Type
Drug
Intervention Name(s)
Amitriptyline
Intervention Description
Initial dose of 12.5mg will be given for 2 days. Then, daily 25mg will be taken for additional 8 weeks
Intervention Type
Drug
Intervention Name(s)
Topiramate
Intervention Description
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 Outcome Measure Information:
Title
Therapeutic response to the analgesic drugs
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?
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