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

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ClinicalTrials.gov Identifier: NCT00719134
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : April 9, 2015
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Rami Burstein, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Episodic Migraine
Interventions Drug: Maxalt
Drug: placebo pill
Drug: placebo pills
Enrollment 76
Recruitment Details 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 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.
Arm/Group Title All Participants
Hide Arm/Group Description 76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
Period Title: Overall Study
Started 76
Completed 66
Not Completed 10
Arm/Group Title All Participants
Hide Arm/Group Description 76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
Overall Number of Baseline Participants 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants
40.6  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants
Female
65
  85.5%
Male
11
  14.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 76 participants
76
Headache intensity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 76 participants
4.6  (1.8)
[1]
Measure Description: 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).
1.Primary Outcome
Title Change in Headache Intensity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
For the primary endpoint, change in headache intensity from baseline to 2 hours after treatment, we used generalized linear mixed models with a normal random component and a logarithmic link function to analyze the pain scores.
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 66
Mean (95% Confidence Interval)
Unit of Measure: percent change
percent change with Maxalt
-47.6
(-53.0 to -41.5)
percent change with placebo
-20.7
(-26.7 to -14.3)
2.Secondary Outcome
Title Pain Free at 2 Hours After Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
For the secondary endpoint, the proportion of patients who were free from pain 2 hours after treatment, we used a mixed-effects logistic regression model to analyze the individual dichotomous outcomes.
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients pain free
pain free with maxalt
25.5
(17.2 to 36.2)
pain free with placebo
6.6
(3.4 to 12.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maxalt Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Maxalt Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maxalt Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/66 (0.00%)   0/66 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Maxalt Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   11/66 (16.67%)   11/66 (16.67%) 
Nervous system disorders     
Chest tightness  [1]  6/66 (9.09%)  5/66 (7.58%) 
Heart palpitation  [1]  4/66 (6.06%)  6/66 (9.09%) 
Throat tightness  [1]  7/66 (10.61%)  4/66 (6.06%) 
Skin sensitivity  [1]  6/66 (9.09%)  3/66 (4.55%) 
Gastrointestinal  [1]  8/66 (12.12%)  3/66 (4.55%) 
Drowsiness  [1]  9/66 (13.64%)  1/66 (1.52%) 
Indicates events were collected by systematic assessment
[1]
Expected medication side effect
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.
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
Responsible Party: Rami Burstein, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00719134     History of Changes
Other Study ID Numbers: 2007-P-000220
First Submitted: July 18, 2008
First Posted: July 21, 2008
Results First Submitted: February 10, 2015
Results First Posted: April 9, 2015
Last Update Posted: April 9, 2015