STOPAIN in the Treatment of a Single Migraine Attack

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Menthol

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 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