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

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. Identifier: NCT00443352
Recruitment Status : Completed
First Posted : March 6, 2007
Results First Posted : May 26, 2014
Last Update Posted : May 26, 2014
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Duloxetine Duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)

Participant Flow:   Overall Study

  Baseline Characteristics

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
Duloxetine Completers duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)

Baseline Measures
   Duloxetine Completers 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 38.4  (11.4) 
[Units: Participants]
Female   20 
Male   7 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   5 
White   22 
More than one race   0 
Unknown or Not Reported   0 

  Outcome Measures

1.  Primary:   Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.   [ 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). ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
This trial was uncontrolled. Five of the 27 subjects did not complete.

  More Information

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 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