Philadelphia, Pennsylvania 19107

  • 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.


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


NCT ID:

NCT00443352


Primary Contact:

Principal Investigator
William B. Young, MD
Thomas Jefferson University

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


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19107
United States

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

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2022

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