The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
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Purpose
Evidence-based medicine depends on distinguishing between pharmacological effects and placebo effects in randomized controlled trials (RCT). This proposal seeks to rigorously investigate fundamental questions concerning pharmacological effects, placebo effects and their interactions. Relief of symptoms of acute migraine will be the test condition for this scientific experiment because of migraine's evident clinical significance and the possibility of using participants as their own control during sequential acute migraine attacks. Our overall goal is to elucidate how the pharmacological effects of 100 mg rizatriptan (an FDA-proven effective medication for acute migraine) and the effects of placebo treatment can be modified by varied knowledge and/or expectation ("contextual") conditions. Such knowledge has the possibility to suggest potentially more efficient methodologies to test new medications that can be used to augment and enhance the apparatus of the RCT.
General Aim: To elucidate and clarify what is a pharmacological effect and what is a placebo effect, how such effects vary in different knowledge/expectations contexts, and mutually constitute one another and interact.
General Hypothesis: The measured pharmacological effect of an effective medication (rizatriptan) and the measured effect of placebo treatment are determined significantly by different knowledge/expectations contexts.
| Condition | Intervention | Phase |
|---|---|---|
|
Episodic Migraine |
Drug: Maxalt Drug: placebo pill Drug: placebo pills |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache |
- The primary outcome will be the proportion of patients who report that they are pain free at 2 hours. [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
- The secondary outcome will be pain response at 2 hours. Pain response is defined as the proportion of patients who report a reduction in pain intensity that is greater than one unit on the four point scale. [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
| Enrollment: | 76 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Maxalt administration at onset of migraine
|
Drug: Maxalt
anti-migraine drug
Other Name: rizatriptan
|
| Placebo Comparator: 2 |
Drug: placebo pill
placebo pills
|
| Experimental: 3 |
Drug: Maxalt
anti-migraine drug
Other Name: rizatriptan
|
| Placebo Comparator: 4 |
Drug: placebo pills
placebo pills
|
| Experimental: 5 |
Drug: Maxalt
anti-migraine drug
Other Name: rizatriptan
|
| Experimental: 6 |
Drug: placebo pills
placebo pills
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| United States, Massachusetts | |
| Pain Clinic at Beth Israel Deaconess Medical Center | |
| Brookline, Massachusetts, United States, 02445 | |
| Principal Investigator: | Rami Burstein, PhD | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| Responsible Party: | Rami Burstein, Professor, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00719134 History of Changes |
| Other Study ID Numbers: | 2007-P-000220 |
| Study First Received: | July 18, 2008 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Headache Migraine Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Rizatriptan Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013