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Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00386880
First received: October 11, 2006
Last updated: August 4, 2014
Last verified: August 2014
Results First Received: August 5, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Migraine
Intervention: Other: Sounds

  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
Subjects With Episodic Migraine With Allodynia These are the subjects with episodic migraine with allodynia.
Subjects With Episodic Migraine Without Allodynia These are the subjects with episodic migraine without allodynia.

Participant Flow:   Overall Study
    Subjects With Episodic Migraine With Allodynia     Subjects With Episodic Migraine Without Allodynia  
STARTED     30     8  
COMPLETED     30     8  
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
Subjects With Episodic Migraine Subjects with less than 8 distict migraine episodes per month.

Baseline Measures
    Subjects With Episodic Migraine  
Number of Participants  
[units: participants]
  38  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     38  
>=65 years     0  
Gender  
[units: participants]
 
Female     30  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     38  



  Outcome Measures

1.  Primary:   Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine   [ Time Frame: Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia. ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Abraham A. Ashkenazi, MD-Principal Investigator
Organization: Doylestown Hospital
phone: 215-625-2894
e-mail: aashkenazi2001@yahoo.com


Publications of Results:

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00386880     History of Changes
Other Study ID Numbers: AA-Phono-CA
Study First Received: October 11, 2006
Results First Received: August 5, 2012
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board