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A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache

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ClinicalTrials.gov Identifier: NCT00443352
Recruitment Status : Completed
First Posted : March 6, 2007
Results First Posted : May 26, 2014
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Migraine
Intervention Drug: duloxetine
Enrollment 27

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Duloxetine
Hide Arm/Group Description Duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
Period Title: Overall Study
Started 27
Completed 22
Not Completed 5
Arm/Group Title Duloxetine Completers
Hide Arm/Group Description duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
38.4  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
20
  74.1%
Male
7
  25.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  18.5%
White
22
  81.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.
Hide Description Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).
Time Frame Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants for analysis was modified intention to treat - anyone who took at least one dose of duloxetine
Arm/Group Title Duloxetine
Hide Arm/Group Description:
duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: days
4.5  (3.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine
Hide Arm/Group Description duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
All-Cause Mortality
Duloxetine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine
Affected / at Risk (%) # Events
Total   0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duloxetine
Affected / at Risk (%) # Events
Total   15/27 (55.56%)    
Gastrointestinal disorders   
Nausea *  8/27 (29.63%)  8
General disorders   
Dry mouth *  5/27 (18.52%)  5
Fatigue *  2/27 (7.41%)  2
*
Indicates events were collected by non-systematic assessment
This trial was uncontrolled. Five of the 27 subjects did not complete.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: William B Young, MD
Organization: Thomas Jefferson University
Phone: 215-955-2243
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00443352     History of Changes
Other Study ID Numbers: Protocol #: F1J-MC-I
First Submitted: March 5, 2007
First Posted: March 6, 2007
Results First Submitted: February 19, 2014
Results First Posted: May 26, 2014
Last Update Posted: May 26, 2014