Trial Outcomes & Findings for Research Study to Determine Sensitivity to Gentle Touch and Pressure During an Active Migraine Attack. (NCT NCT00329771)

Results Overview

Brush allodynia (discomfort with normal sensation) measured at pre-specified sites on the head, neck and forearms using a 100 mm visual analog scale (VAS). After each series of brushes the patient will be asked to rate the level of discomfort from "normal sensation" to "extremely painful or unpleasant" using a 100 mm visual analog scale (VAS).

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

allodynia assessed within 4 hours from onset of migraine head pain

Results posted on

2024-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Episodic Migraineurs Eligible subjects with episodic migraine (with or without aura)
Overall Study STARTED	28
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Research Study to Determine Sensitivity to Gentle Touch and Pressure During an Active Migraine Attack.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Episodic Migraineurs n=28 Participants Eligible subjects with episodic migraine (with or without aura)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: allodynia assessed within 4 hours from onset of migraine head pain

Population: Participants who completed allodynia test

Brush allodynia (discomfort with normal sensation) measured at pre-specified sites on the head, neck and forearms using a 100 mm visual analog scale (VAS). After each series of brushes the patient will be asked to rate the level of discomfort from "normal sensation" to "extremely painful or unpleasant" using a 100 mm visual analog scale (VAS).

Outcome measures

Outcome measures
Measure	Episodic Migraineurs n=25 Participants Eligible subjects with episodic migraine (with or without aura)
Proportion of Subjects With Allodynia During a Migraine Attack	15 participants

Adverse Events

Episodic Migraineurs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Abraham A. Ashkenazi, M.D./Principal Investigator

Doylestown Hospital, Pennsylvania

Phone: 215-625-2894

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place