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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Rambam Health Care Campus.
Recruitment status was:  Active, not recruiting
Information provided by:
Rambam Health Care Campus Identifier:
First received: July 10, 2010
Last updated: July 12, 2010
Last verified: December 2007

Mechanism-based choice of therapy for pain:

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

Condition Intervention
Drug: Amitriptyline
Drug: Topiramate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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?

Resource links provided by NLM:

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Therapeutic response to the analgesic drugs [ Time Frame: 2 months ]

Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01161017

Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

Responsible Party: Prof. David Yarnitsky, Rambam Medical Center Identifier: NCT01161017     History of Changes
Other Study ID Numbers: Migraine06CTIL
Study First Received: July 10, 2010
Last Updated: July 12, 2010

Keywords provided by Rambam Health Care Campus:
migraine patients

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents processed this record on May 23, 2017