STOPAIN in the Treatment of a Single Migraine Attack

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01687101
First received: September 13, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Migraine
Drug: STOPAIN topical gel

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Efficacy and Tolerability of STOPAIN in the Treatment of a Single Migraine Attack

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Efficacy of STOPAIN in the Acute Treatment of Migraine [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
    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 (no pain, mild pain, moderate pain, severe pain).


Secondary Outcome Measures:
  • evaluate the tolerability, safety, and sustained pain freedom of STOPAIN [ Time Frame: 2 to 24 hours ] [ Designated as safety issue: No ]
    • To evaluate the tolerability and safety of STOPAIN in the acute treatment of migraine as measured by the frequency and severity of adverse events, frequency of serious adverse events and discontinuations due to adverse events
    • To evaluate STOPAIN for sustained pain freedom from 2 to 24 hours.


Estimated Enrollment: 25
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STOPAIN topical gel
STOPAIN gel, 2 or 4 pumps of gel, one or two applications, 2 hours
Drug: STOPAIN topical gel

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687101

Contacts
Contact: Stephen D. Silberstein, M.D. 215-955-2243 Stephen.Silberstein@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Stephen D. Silberstein, M.D.    215-955-2243    Stephen.Silberstein@jefferson.edu   
Principal Investigator: Stephen D. Silberstein, M.D.         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Stephen D Silberstein, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01687101     History of Changes
Other Study ID Numbers: SDS/STPAIN/01
Study First Received: September 13, 2012
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Menthol
Antipruritics
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014