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The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache

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ClinicalTrials.gov Identifier: NCT00719134
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : April 9, 2015
Last Update Posted : April 9, 2015
Information provided by (Responsible Party):

Study Description
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 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 or disease Intervention/treatment Phase
Episodic Migraine Drug: Maxalt Drug: placebo pill Drug: placebo pills Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
Study Start Date : September 2008
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
Drug Information available for: Rizatriptan
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Change in Headache Intensity [ Time Frame: 2 hours after treatment ]
    The primary outcome measure was the change in headache between the baseline pain score recorded 30 min after the onset of headache and the pain score recorded 2 hours later as measured on a visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable).

Secondary Outcome Measures :
  1. Pain Free at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ]
    A secondary measure of attack outcome was based on categorical classification of the pain freedom (pain score = 0) 2.5 hours after onset of headache.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00719134

United States, Massachusetts
Pain Clinic at Beth Israel Deaconess Medical Center
Brookline, Massachusetts, United States, 02445
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Principal Investigator: Rami Burstein, PhD Beth Israel Deaconess Medical Center
More Information

Responsible Party: Rami Burstein, Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00719134     History of Changes
Other Study ID Numbers: 2007-P-000220
First Posted: July 21, 2008    Key Record Dates
Results First Posted: April 9, 2015
Last Update Posted: April 9, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs