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 because the information has not been verified recently.
Verified December 2007 by Rambam Health Care Campus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01161017
First received: July 10, 2010
Last updated: July 12, 2010
Last verified: December 2007
  Purpose

Mechanism-based choice of therapy for pain:

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


Condition Intervention
Migraine
Drug: Amitriptyline
Drug: Topiramate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161017

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

No publications provided

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

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
Amitriptyline, perphenazine drug combination
Topiramate
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Anticonvulsants
Neuroprotective Agents

ClinicalTrials.gov processed this record on July 24, 2014