This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Rami Burstein, Beth Israel Deaconess Medical Center Identifier:
First received: July 18, 2008
Last updated: April 8, 2015
Last verified: April 2015

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
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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 76
Study Start Date: September 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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


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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00719134     History of Changes
Other Study ID Numbers: 2007-P-000220
Study First Received: July 18, 2008
Results First Received: February 10, 2015
Last Updated: April 8, 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 processed this record on September 21, 2017