Status:
COMPLETED
The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Episodic Migraine
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Evidence-based medicine depends on distinguishing between pharmacological effects and placebo effects in randomized controlled trials (RCT). This proposal seeks to rigorously investigate fundamental q...
Eligibility Criteria
Inclusion
- Patients will be considered for this study if they suffer from classical or common migraine for at least 3 years.
- Candidates will recruited from the clinical case load of Dr. Zahid Bajwa and the headache and pain management center at BIDMC.
- Only patients older than 18 years of age,
- Able to communicate clearly in English,
- Able to give an informed consent will be considered as candidates.
- No limitation of gender or race is justified and thus, it is open to all patients fulfilling criteria for migraine type headache.
- Patients will be able to withdraw from the study at any time.
- They will be included in the study if they meet the criteria for migraine with or without aura (Headache-classification-committee-of-the-International-Headache-Society 1988), if they had \>4 migraine attacks each month for the previous year.
Exclusion
- Exclusion criteria will include cardiovascular or cerebrovascular disorders,
- Cardiac risk factors and liver disease,
- Uncontrolled hypertension,
- Peripheral and central nervous system disorders that affect sensory functions (such as sensory neuropathies and chronic pain),
- The use of opiates or other analgesic drugs for any reason, and the use of other prophylactic anti-migraine drugs.
- Any patient with active hepatitis or elevated liver enzymes (based on their BIDMC medical record) will be excluded as well.
- Employees who are under the direct supervision of the investigators will not participate in the study.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00719134
Start Date
September 1 2008
End Date
December 1 2013
Last Update
April 9 2015
Active Locations (1)
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1
Pain Clinic at Beth Israel Deaconess Medical Center
Brookline, Massachusetts, United States, 02445