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Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386880
First Posted: October 12, 2006
Last Update Posted: August 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Jefferson University
Results First Submitted: 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 
Overall Participants Analyzed 
[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
First Submitted: October 11, 2006
First Posted: October 12, 2006
Results First Submitted: August 5, 2012
Results First Posted: August 22, 2014
Last Update Posted: August 22, 2014