A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: duloxetine
Intervention description: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility 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