STOPAIN in the Treatment of a Single Migraine Attack
Condition: Migraine; Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      This is an open label pilot study of 25 subjects with a diagnosis of episodic migraine with
      or without aura. STOPAIN is an over-the-counter product that is used for the temporary relief
      of minor aches and pains of muscles and joints associated with simple backache, arthritis,
      strains, bruises and sprains. We plan to have subjects apply the product during a single
      migraine attack to see if it will alleviate the headache pain and associated symptoms.
    

Detailed description: 
      This is an open label, 2 visit, pilot study of 25 subjects with a diagnosis of episodic
      migraine with or without aura according to the International Classification of Headache
      Disorders (2nd Edition-2004).

      Subjects will be screened at Visit 1 after being properly consented for participation in the
      study. Screening procedures will include assessment of the medical history, headache history,
      current medications, vital signs, height and weight measurements and a urine pregnancy test
      for women of childbearing potential. Investigators will determine the eligibility of study
      subjects. Subjects will be instructed on how and when to apply the topical gel to treat a
      migraine attack. In addition, subjects will be instructed how to complete the take home
      diary. The study medication will be used at home to treat a single migraine attack.

      At the time of at-home treatment the subject will apply the study medication. The gel will be
      applied to the area below and abutting the back base of the skull to base of neck and span
      from behind and between both ears. The quantity shall be two pumps from the metered dosing
      bottle. The best way to apply is to pump once onto the fingertips and apply the gel to
      one-half of the application area and pump again onto the fingertips and apply the gel to the
      other half of the application area. Massage in for 5 to 10 seconds to make sure there is
      reasonably uniform coverage. (Do not cover with cloth or bandage or lie down on a pillow
      until the gel has completely dried - about 10 minutes or so.) Do not get any of the gel into
      the eyes or onto mucus membranes. The gel is not toxic but will cause a burning sensation to
      eyes or mucus membranes. Wash hands with soap and warm water after application. The gel will
      give rise to a cooling sensation and to it may feel like a mild to moderate stinging or
      burning sensation. That is normal. Anything more than a mild to moderate stinging or burning
      sensation is not expected and should be noted in diary. If there has been no reduction in
      symptoms after 30 minutes repeat the application. If there is no relief after 2 hours the
      subject may use other rescue medication.

      Completed subject diaries will provide data on headache severity and the presence or absence
      of nausea, vomiting, photophobia and phonophobia. Time of resolution of both the headache and
      accompanying symptoms will be collected. The subjects will record migraine pain severity and
      the presence or absence of associated symptoms at 30, 60, 90 minutes and 2, 4, and 24 hours
      after the administration of study drug.

      Subjects will be asked to treat a single migraine attack within 8 weeks of Visit 1. After
      treating the attack and completing the diary, they will be asked to return to Jefferson
      Headache Center for a final visit (Visit 2) or to return the diary and other study supplies
      by mail. Shipping materials will be provided to each participant.
    

Intervention name(s): STOPAIN topical gel
Intervention type(s): Drug
Intervention description(s): STOPAIN topical gel is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
Other intervention name(s): Topical menthol 6% gel
Intervention MeSH terms: Menthol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute migraine; acute migraine treatment; topical treatment