MigraineNCT01687101
STOPAIN in the Treatment of a Single Migraine Attack
A study testing STOPAIN topical gel in people with Migraine and Headache, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- STOPAIN topical gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Study to Evaluate the Efficacy and Tolerability of STOPAIN in the Treatment of a Single Migraine Attack
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.
Read the 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.
- Being tested
- STOPAIN topical gel
- Keywords
- acute migraine, acute migraine treatment, topical treatment
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOPAIN topical gelDrug
Also called Topical menthol 6% gel
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: STOPAIN topical gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hours after the time of gel application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen D Silberstein, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687101
- Sponsor's protocol ID
- SDS/STPAIN/01
- Status last verified
- May 2017
- First submitted
- 13 Sep 2012
- Last updated
- 9 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Tolerability of STOPAIN in the Treatment of a Single Migraine Attack
- ClinicalTrials.gov ID
- NCT01687101
- Acronym / sponsor ID
- SDS/STPAIN/01
- Keywords
- acute migraine, acute migraine treatment, topical treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Posted 27 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STOPAIN topical gel | Experimental | Drug: STOPAIN topical gelSTOPAIN 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STOPAIN topical gelAlso: Topical menthol 6% gelSTOPAIN 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. | Drug | STOPAIN topical gel |
Primary outcome
Efficacy of STOPAIN in the Acute Treatment of Migraine
Time frame: 2 hours after the time of gel application
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D Silberstein, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOPAIN topical gel in people with Migraine and Headache, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of STOPAIN in the Acute Treatment of Migraine (time frame: 2 hours after the time of gel application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.