STOPAIN in the Treatment of a Single Migraine Attack

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.

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
criteria for at least one year prior to screening

- Subjects who experience between 1 and 10 migraine attacks (inclusive) per month
(during the previous 6 months) with no more than 15 days of headache per month.

- 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 investigator's 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 who have participated in an investigational drug trial in the 30 days prior
to the screening visit

- Subjects who currently have or have had a history of basilar or hemiplegic migraine