A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Migranal nasal spray at 1 hour; Migranal nasal spray at 4 hour
Intervention description: Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.; Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.
Intervention MeSH terms: Dihydroergotamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a research study looking at Migranal (study drug) in the treatment of two migraine
      attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us
      al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a
      headache. It has been noted in several studies that in patients with migraine, seventy nine
      percent of the patients experienced allodynia on the facial skin on the same side as the
      headache. Understanding more about allodynia may help us understand how the pain system works
      in migraine.

      This study will compare the differences, if any, in attacks treated early with study drug (at
      1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat one
      attack early and one attack late for this study. If the first attack you treat is early (at 1
      hour following onset of throbbing pain) then the second attack you treat should be late (at 4
      hours following onset of throbbing pain).

      It is hoped that this study will provide information on the use of Migranal in subjects who
      have cutaneous allodynia. The results from this study may be used in the development of
      larger clinical trials. The study drug is a medication that is taken in the form of nasal
      spray.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between the ages of 18 and 65, inclusive

          -  Subjects diagnosed with episodic migraine, with or without aura according to IHS
             (International Headache Society) criteria (Appendix B) for at least one-year prior to
             screening

          -  Subjects who experience between 3-10 migraine attacks (inclusive) per month (during
             the previous 6 months) with no more than 15 days of headache per month.

          -  Subjects who report their migraine pain quality as pulsating/ throbbing.

          -  Subject experiences episodic migraine associated with cutaneous allodynia, as
             determined by the Cutaneous Allodynia screening tool and investigator.

          -  Subject is using or agrees to use for the duration of participation a medically
             acceptable form of contraception (as determined by investigator), if female of
             child-bearing potential

          -  Subjects who are able to understand and comply with all study procedures.

          -  Subject provides written informed consent prior to any screening procedures being
             conducted

        Exclusion Criteria:

          -  Pregnant and/or lactating women

          -  Subjects who, in the investigators opinion, have a history or have evidence of a
             medical or psychiatric condition that would expose them to an increased risk of a
             significant adverse event or would interfere with the assessments of efficacy and
             tolerability during this trial

          -  Subjects with an abnormal ECG that, in the investigators opinion, would expose them to
             increased risk of adverse events or interfere with study drug and/or analysis of
             efficacy/tolerability

          -  Subjects currently using, or expecting to use during the trial, CYP 3A4(CYP3A4 enzyme)
             inhibitors (such as protease inhibitors and macrolide antibiotics)

          -  Subjects with severely impaired hepatic or renal function, as determined by the
             investigator

          -  Subjects who have participated in an investigational drug trial in the 30 days prior
             to the screening visit

          -  Subjects who currently have or have a history of basilar or hemiplegic migraine

          -  Subjects who have previously shown hypersensitivity to ergot alkaloids

          -  Subjects who have a history of non-response to DHE-45 (dihydroergotamine) or
             Migranal®, as determined by investigator

          -  Subjects with uncontrolled hypertension

          -  Subjects who currently have or who have a history of ischemia and/or vasospastic
             coronary artery disease

          -  Subjects who, in the investigators opinion, have significant risk factors of coronary
             artery disease