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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rami Burstein, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00719134
First received: July 18, 2008
Last updated: July 16, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


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 ]

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

  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
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 ClinicalTrials.gov identifier: NCT00719134

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
Investigators
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: July 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Contraceptives, Oral
Rizatriptan
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014