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

Episodic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719134
• Other study ID #: 2007-P-000220
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2008
• Last updated: April 8, 2015
• Start date: September 2008
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Maxalt
anti-migraine drug
• placebo pill
placebo pills
• placebo pills
placebo pills

Locations

Country	Name	City	State
United States	Pain Clinic at Beth Israel Deaconess Medical Center	Brookline	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Headache Intensity	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).	2 hours after treatment	No
Secondary	Pain Free at 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.	2 hours after treatment	No