STOPAIN in the Treatment of a Single Migraine Attack

NCT01687101 | Completed Results

• 1 other identifier: SDS/STPAIN/01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine; Headache

Keywords

acute migraine; acute migraine treatment; topical treatment

Outcome Measures

Primary Outcomes (1)

• Efficacy of STOPAIN in the Acute Treatment of Migraine

  To evaluate the efficacy of STOPAIN in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level equal to "no pain") at 2 hours post dose using a four point numeric rating scale (0=no pain, 1= mild pain, 2=moderate pain, 3=severe pain).

  2 hours after the time of gel application

Study Arms (1)

STOPAIN topical gel

EXPERIMENTAL

STOPAIN gel which 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.

Drug: STOPAIN topical gel

Interventions

STOPAIN topical gel DRUG

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.

Also known as: Topical menthol 6% gel

STOPAIN topical gel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Menthol; Gels

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Stephen D Silberstein, MD
• Organization: Thomas Jefferson University, Jefferson Headache Center

bruce.smith@jefferson.edu

215-955-2243

Study Officials

• Stephen D Silberstein, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 18, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 9, 2017
• Results First Posted: April 27, 2015

Record last verified: 2017-05

Locations

US (1)