Trial Outcomes & Findings for STOPAIN in the Treatment of a Single Migraine Attack (NCT NCT01687101)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

2 hours after the time of gel application

Results posted on

2017-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	STOPAIN Topical Gel 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 Study STARTED	32
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	STOPAIN Topical Gel 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 Study Lost to Follow-up	7

Baseline Characteristics

STOPAIN in the Treatment of a Single Migraine Attack

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STOPAIN Topical Gel n=32 Participants 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.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	28 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Region of Enrollment United States	32 participants n=99 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	STOPAIN Topical Gel n=25 Participants 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.
Efficacy of STOPAIN in the Acute Treatment of Migraine	1.92 units on a scale Interval 0.0 to 3.0

Adverse Events

STOPAIN Topical Gel

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	STOPAIN Topical Gel n=32 participants at risk 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.
Skin and subcutaneous tissue disorders Stinging	3.1% 1/32 • Number of events 1 • 24 hours after application of topical gel.
Skin and subcutaneous tissue disorders Burning sensation.	3.1% 1/32 • Number of events 1 • 24 hours after application of topical gel.

Additional Information

Stephen D Silberstein, MD

Thomas Jefferson University, Jefferson Headache Center

Phone: 215-955-2243

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place