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Smell Sensitivity in Chronic Migraine: A Case-Control Study

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01687088
First received: September 13, 2012
Last updated: October 21, 2014
Last verified: October 2014
Results First Received: July 14, 2014  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Chronic Migraine
Olfactory Acuity

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Chronic Migraineurs At least 8 migraine days per week and headache at least 15 days per month.
Controls No significant headache or disability as defined by migraine disability scale.

Participant Flow:   Overall Study
    Chronic Migraineurs   Controls
STARTED   50   50 
COMPLETED   50   50 
NOT COMPLETED   0   0 



  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.
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Reporting Groups
  Description
Chronic Migraineurs At least 8 migraine days per week and headache at least 15 days per month.
Controls No significant headache or disability as defined by migraine disability scale.
Total Total of all reporting groups

Baseline Measures
   Chronic Migraineurs   Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   50   100 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   50   50   100 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   40   40   80 
Male   10   10   20 
Region of Enrollment 
[Units: Participants]
     
United States   50   50   100 


  Outcome Measures

1.  Primary:   Comparison of UPSIT Scores Between Subjects and Controls at Two Time Points   [ Time Frame: Chronic migraineurs up to 12 months. Controls up to 2 weeks. ]


  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
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  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: Michael J. Marmura, MD
Organization: Thomas Jefferson University
phone: 215-955-2243
e-mail: michael.marmura@jefferson.edu



Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01687088     History of Changes
Other Study ID Numbers: MJM/Olfactory/002
Study First Received: September 13, 2012
Results First Received: July 14, 2014
Last Updated: October 21, 2014
Health Authority: United States: Institutional Review Board