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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01161017
First Posted: July 13, 2010
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
d_yarnitsky, Rambam Health Care Campus
  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: 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?

Resource links provided by NLM:


Further study details as provided by d_yarnitsky, Rambam Health Care Campus:

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

Enrollment: 67
Actual Study Start Date: July 2008
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161017


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

Responsible Party: d_yarnitsky, Head of Neurology Department, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01161017     History of Changes
Other Study ID Numbers: Migraine06CTIL
First Submitted: July 10, 2010
First Posted: July 13, 2010
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by d_yarnitsky, 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
Topiramate
Amitriptyline
Amitriptyline, perphenazine drug combination
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
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