Trial Outcomes & Findings for Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs (NCT NCT00386880)

Results Overview

Measurement of phonophobia: determine sound aversion threshold (SAT), measured in dB during a migraine attack in subjects with and in subjects without allodynia.

Recruitment status

COMPLETED

Target enrollment

38 participants

Primary outcome timeframe

Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.

Results posted on

2014-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With Episodic Migraine With Allodynia These are the subjects with episodic migraine with allodynia.	Subjects With Episodic Migraine Without Allodynia These are the subjects with episodic migraine without allodynia.
Overall Study STARTED	30	8
Overall Study COMPLETED	30	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Episodic Migraine n=38 Participants Subjects with less than 8 distict migraine episodes per month.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants

PRIMARY outcome

Timeframe: Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.

Measurement of phonophobia: determine sound aversion threshold (SAT), measured in dB during a migraine attack in subjects with and in subjects without allodynia.

Outcome measures

Outcome measures
Measure	Subjects With Episodic Migraine With Allodynia n=30 Participants These are subjects with episodic migraine with allodynia	Subjects With Episodic Migraine Without Allodynia n=8 Participants These are subjects with episodic migraine without allodynia
Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine	27 participants	6 participants

Adverse Events

Subjects With Episodic Migraine

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, MD-Principal Investigator

Doylestown Hospital

Phone: 215-625-2894

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place