A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This is a three visit trial consisting of a screening visit, one follow-up visit and a
      termination visit. Subjects will be screened using the Cutaneous Allodynia Screening Tool
      (Appendix A) and the investigator will determine whether or not the subject experiences
      episodic migraine headaches associated with cutaneous allodynia. Those subjects who test
      positive for the afore-stated will then proceed with the treatment phase of the project.

      Migranal® will be taken by the subject at home at 1-hour following the onset of throbbing
      pain for one of the two qualifying migraine attacks and at 4-hours following onset of
      throbbing pain for the second qualifying migraine attack. 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.
      Cutaneous allodynia assessments will be made periodically prior to and after administration
      of study drug. Subjects will be asked to return to the center within 1 week of treating each
      attack. Subjects will be instructed to treat their 1st qualifying attack within 6 weeks of
      the screening visit and their 2nd qualifying attack within 6 weeks of their follow-up visit
      1.

      Migraine pain and associated symptoms assessments will be measured by the subjects for
      24-hours from the administration of study drug for each attack.
    

Intervention name(s): Migranal nasal spray at 1 hour; Migranal nasal spray at 4 hour
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Dihydroergotamine (DHE); Dihydroergotamine (DHE)
Intervention MeSH terms: Dihydroergotamine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment