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

NCT ID: NCT00719134

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

Episodic Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

1

Maxalt administration at onset of migraine

Group Type: EXPERIMENTAL

Maxalt

Intervention Type: DRUG

anti-migraine drug

2

Group Type: PLACEBO_COMPARATOR

placebo pill

Intervention Type: DRUG

placebo pills

3

Group Type: EXPERIMENTAL

Maxalt

Intervention Type: DRUG

anti-migraine drug

4

Group Type: PLACEBO_COMPARATOR

placebo pills

Intervention Type: DRUG

placebo pills

5

Group Type: EXPERIMENTAL

Maxalt

Intervention Type: DRUG

anti-migraine drug

6

Group Type: EXPERIMENTAL

placebo pills

Intervention Type: DRUG

placebo pills

Interventions

Maxalt

anti-migraine drug

Intervention Type: DRUG

placebo pill

placebo pills

Intervention Type: DRUG

placebo pills

placebo pills

Intervention Type: DRUG

Other Intervention Names

rizatriptan

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rami Burstein

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rami Burstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Pain Clinic at Beth Israel Deaconess Medical Center

Brookline, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24401940 (View on PubMed)

Other Identifiers

2007-P-000220

Identifier Type: -

Identifier Source: org_study_id