The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache - Full Text View

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00719134

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 Drug: no treatment	Phase IV

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Rizatriptan Rizatriptan Benzoate

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Maxalt administration at onset of migraine	Drug: Maxalt anti-migraine drug
2: Placebo Comparator	Drug: placebo pill placebo pills
3: Experimental	Drug: Maxalt anti-migraine drug
4: Placebo Comparator	Drug: placebo pills placebo pills
5: Experimental	Drug: Maxalt anti-migraine drug
6: Experimental	Drug: placebo pills placebo pills
7: No Intervention	Drug: no treatment no treatment

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719134

Contacts

Contact: Zahid Bajwa, M.D.	(617) 278-8037	zbajwa@bidmc.harvard.edu
Contact: Rami Burstein, Ph.D.	617 667 0806	rburstei@bidmc.harvard.edu

Locations

United States, Massachusetts
Pain Clinic at Beth Israel Deaconess Medical Center
Brookline, Massachusetts, United States, 02445

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	BIDMC ( Rami Burstein, Associate Professor and Vice Chairman Research, Dept. of Anesthesia )
Study ID Numbers:	2007-P-000220
Study First Received:	July 18, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00719134 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Serotonin Agonists
Neurotransmitter Agents
Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Rizatriptan
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Headache Disorders, Primary

Rizatriptan
Brain Diseases
Pharmacologic Actions
Headache Disorders
Serotonin Agents
Migraine Disorders

ClinicalTrials.gov processed this record on July 02, 2009