Trial Outcomes & Findings for A Research Study to Examine Cutaneous Allodynia and Cluster Headache (NCT NCT00329836)

Results Overview

Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.

Recruitment status

COMPLETED

Target enrollment

41 participants

Primary outcome timeframe

Allodynia was assessed at the screening visit

Results posted on

2025-02-28

Participant Flow

Subjects with cluster headache recruited from Jefferson Headache Center office practice or community. First subject enrolled 7/5/05. Last subject enrolled 6/9/06.

Participant milestones

Participant milestones
Measure	Subjects With Cluster Headache Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Research Study to Examine Cutaneous Allodynia and Cluster Headache

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Cluster Headache n=41 Participants Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44.9 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Allodynia was assessed at the screening visit

Population: All enrolled subjects were analyzed

Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.

Outcome measures

Outcome measures
Measure	Subjects With Cluster Headache n=41 Participants Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
Prevalence of Allodynia in Subjects With Cluster Headache	20 participants

Adverse Events

Subjects With Cluster Headache

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 Ashkenazi, M.D./ Prinicpal Investigator

Doylestown Hospital

Phone: 215-625-2894

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place