View Clinical Trial (Medical Research Study)

A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache - NCT00443352-19107(Clinical Trial 164539)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Philadelphia
State:  
PA
Zip Code: 19107
Conditions: Migraine
Purpose: This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.
Study summary:
Criteria: Inclusion Criteria: - Subject is male or female between the ages of 18 and 65, inclusive - Subject has an IHS diagnosis of migraine with or without aura for at least one-year prior to screening - Subject has experienced between 4 and 10 migraine headaches per month (inclusive) over the past six months, with at least 24 hours separating attacks - Subject has less than 15 total headache days per month - Subject is able to differentiate migraine attacks from other headache types, if applicable - Subjects daily medications (for any indication) have remained at a stable dose for the 60 days preceding screening - Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator and mutually agreed upon with patient), if female of child-bearing potential - Subjects currently taking a single agent for the prevention of migraine must be on a stable dose (unchanged for 2 months) prior to study entry - Subject has negative urine pregnancy test prior to study entry, if female of child-bearing potential - Subject is able to understand and comply with all study requirements - Subject provides written informed consent prior to any screening procedures being conducted EXCLUSION CRITERIA: - Subjects with onset of migraine after 50 years of age - Subjects who have been previously treated or are currently being treated with duloxetine - Subjects who have failed greater than 3 adequate trials of other medications the prevention of migraine, as determined by investigator - Subjects who have a known hypersensitivity to duloxetine or any of the inactive ingredients - Subject has taken any medication which has been shown to be effective for migraine prophylaxis, on a daily basis within the 4 weeks prior to screening or at any time during participation in the study, for any indication. - Subjects with a history of significant drug or alcohol abuse within the past year - Subjects with major depressive disorder or who have had a suicidal ideation in the 3 months prior to screening or have a history of attempted suicide - Subjects who have a Beck Depression Inventory score of > 18 at screening - Subjects who have > 0 on question number 9 of Beck Depression Inventory (Suicidal Thoughts or Wishes question) - Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit - Subjects with a current or history of a hepatic or renal disorder - Subjects with uncontrolled narrow angle glaucoma - Subjects who have experienced significant side effects from two different SSRI and/or SNRI therapies, as determined by investigator - Subjects with uncontrolled restless legs syndrome, as determined by investigator
Study is available at: Jefferson Headache Center
Philadelphia, PA 19107
United States

Primary Contact:
Meryl Latsko, MD, MPH
Email: Meryl.Latsko@jefferson.edu
Phone: 215-955-9477

Secondary Contact:
Meryl Latsko, MD, MPH
Email: meryl.latsko@jefferson.edu
Phone: 215-955-9477
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.