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

Primary Purpose

Episodic Migraine

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Maxalt
placebo pill
placebo pills
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Episodic Migraine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pain Clinic at Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

4

5

6

Arm Description

Maxalt administration at onset of migraine

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
July 18, 2008
Last Updated
April 8, 2015
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00719134
Brief Title
The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
Official Title
The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Migraine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Maxalt administration at onset of migraine
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Maxalt
Other Intervention Name(s)
rizatriptan
Intervention Description
anti-migraine drug
Intervention Type
Drug
Intervention Name(s)
placebo pill
Intervention Description
placebo pills
Intervention Type
Drug
Intervention Name(s)
placebo pills
Intervention Description
placebo pills
Primary Outcome Measure Information:
Title
Change in Headache Intensity
Description
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).
Time Frame
2 hours after treatment
Secondary Outcome Measure Information:
Title
Pain Free at 2 Hours After Treatment
Description
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.
Time Frame
2 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rami Burstein, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Clinic at Beth Israel Deaconess Medical Center
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24401940
Citation
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.
Results Reference
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The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache

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