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STOPAIN in the Treatment of a Single Migraine Attack

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ClinicalTrials.gov Identifier: NCT01687101
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : April 27, 2015
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Migraine
Headache
Intervention Drug: STOPAIN topical gel
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title STOPAIN Topical Gel
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 32
Completed 25
Not Completed 7
Reason Not Completed
Lost to Follow-up             7
Arm/Group Title STOPAIN Topical Gel
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
28
  87.5%
Male
4
  12.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title Efficacy of STOPAIN in the Acute Treatment of Migraine
Hide Description 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).
Time Frame 2 hours after the time of gel application
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STOPAIN Topical Gel
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 25
Mean (Full Range)
Unit of Measure: units on a scale
1.92
(0 to 3)
Time Frame 24 hours after application of topical gel.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title STOPAIN Topical Gel
Hide Arm/Group Description 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.
All-Cause Mortality
STOPAIN Topical Gel
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
STOPAIN Topical Gel
Affected / at Risk (%) # Events
Total   0/32 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
STOPAIN Topical Gel
Affected / at Risk (%) # Events
Total   2/32 (6.25%)    
Skin and subcutaneous tissue disorders   
Stinging  [1]  1/32 (3.13%)  1
Burning sensation.  [2]  1/32 (3.13%)  1
Indicates events were collected by systematic assessment
[1]
Stinging at application site resolved without treatment. Duration of 15 minutes.
[2]
Burning sensation on both hands after applying gel. Duration 20 minutes; severity was mild. Resoved without treatment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Stephen D Silberstein, MD
Organization: Thomas Jefferson University, Jefferson Headache Center
Phone: 215-955-2243
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01687101     History of Changes
Other Study ID Numbers: SDS/STPAIN/01
First Submitted: September 13, 2012
First Posted: September 18, 2012
Results First Submitted: February 19, 2015
Results First Posted: April 27, 2015
Last Update Posted: June 9, 2017