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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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):
Rami Burstein, Beth Israel Deaconess Medical Center

July 18, 2008
July 21, 2008
February 10, 2015
April 9, 2015
April 9, 2015
September 2008
December 2013   (Final data collection date for primary outcome measure)
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).
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 ]
Complete list of historical versions of study NCT00719134 on Archive Site
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.
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 ]
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The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache

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.

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Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Episodic Migraine
  • Drug: Maxalt
    anti-migraine drug
    Other Name: rizatriptan
  • Drug: placebo pill
    placebo pills
  • Drug: placebo pills
    placebo pills
  • Experimental: 1
    Maxalt administration at onset of migraine
    Intervention: Drug: Maxalt
  • Placebo Comparator: 2
    Intervention: Drug: placebo pill
  • Experimental: 3
    Intervention: Drug: Maxalt
  • Placebo Comparator: 4
    Intervention: Drug: placebo pills
  • Experimental: 5
    Intervention: Drug: Maxalt
  • Experimental: 6
    Intervention: Drug: placebo pills
Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 8;6(218):218ra5. doi: 10.1126/scitranslmed.3006175.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Not Provided
Rami Burstein, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
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Principal Investigator: Rami Burstein, PhD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP