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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: April 8, 2015
Last verified: April 2015
Results First Received: February 10, 2015  
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
Condition: Episodic Migraine
Interventions: Drug: Maxalt
Drug: placebo pill
Drug: placebo pills

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of 98 persons pre-screened for eligibility between December 2008 and March 2010, 19 were excluded and 3 declined to participate. The remaining 76 persons signed the consent form, but 10 of them dropped out of the study for various reasons. Participants were recruited from Beth Israel Deaconess Medical Center outpatient clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Reasons for excluding 19 of the pre-screened subjects include chronic migraine, chronic daily headache, tension type headache, fibromyalgia, daily use of opioids, and medication overuse headache. We randomized participants to one of 8 treatment sequences and each patient received 3 treatments with Maxalt and 3 treatments with Placebo.

Reporting Groups
  Description
All Participants 76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.

Participant Flow:   Overall Study
    All Participants  
STARTED     76  
COMPLETED     66  
NOT COMPLETED     10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants 76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  76  
Age  
[units: years]
Mean (Standard Deviation)
  40.6  (12.7)  
Gender  
[units: participants]
 
Female     65  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     76  
Headache intensity [1]
[units: units on a scale]
Mean (Standard Deviation)
  4.6  (1.8)  
[1] pain score at 30 minutes after onset of migraine as measured on a visual analog scale that ranges from 0 (no pain) to 10 (worst pain imaginable).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Headache Intensity   [ Time Frame: 2 hours after treatment ]

2.  Secondary:   Pain Free at 2 Hours After Treatment   [ Time Frame: 2 hours after treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Patients were not asked whether or not they thought the pill they took was maxalt or placebo. Thus, it is not possible to determine their actual level of expectation.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rami Burstein
Organization: Beth Israel Deacxoness Medical Center
phone: 617 735 2832
e-mail: rburstei@bidmc.harvard.edu


Publications of Results:

Responsible Party: Rami Burstein, 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
Results First Received: February 10, 2015
Last Updated: April 8, 2015
Health Authority: United States: Institutional Review Board