View Clinical Trial (Medical Research Study)
A Single-Center, Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19107 |
| Conditions: |
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Migraine |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00443352 |
| Primary Contact: |
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Principal Investigator
William B. Young, MD
Thomas Jefferson University
Meryl Latsko, MD, MPH
Phone: 215-955-9477
Email: meryl.latsko@jefferson.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Philadelphia, Pennsylvania 19107
United States
Meryl Latsko, MD, MPH
Phone: 215-955-9477
Email: Meryl.Latsko@jefferson.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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