A Research Study to Examine Cutaneous Allodynia and Cluster Headache

This study has been completed.

Study NCT00329836 Information provided by Thomas Jefferson University

First Received on May 24, 2006. Last Updated on July 21, 2011 History of Changes

Results First Received: July 21, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Cluster Headache
Intervention:	Other: There are no interventions in the observational study. The symptom of allodynia was measured.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Subjects With Cluster Headache	Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.

Participant Flow: Overall Study

	Subjects With Cluster Headache
STARTED	41
COMPLETED	41
NOT COMPLETED	0

Baseline Characteristics

Reporting Groups

	Description
Subjects With Cluster Headache	Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.

Baseline Measures

	Subjects With Cluster Headache
Number of Participants [units: participants]	41
Age [units: participants]
<=18 years	0
Between 18 and 65 years	41
>=65 years	0
Age [units: years] Mean ± Standard Deviation	44.9 ± 10.5
Gender [units: participants]
Female	19
Male	22
Region of Enrollment [units: participants]
United States	41

Outcome Measures

1. Primary:

Prevalence of Allodynia in Subjects With Cluster Headache [ Time Frame: Allodynia was assessed at the screening visit ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Abraham Ashkenazi, M.D./ Prinicpal Investigator
Organization: Doylestown Hospital
phone: 215-625-2894
e-mail: aashkenazi@yahoo.com

No publications provided

Responsible Party:	Abraham A. Ashkenazi, MD, Doylestown Hospital
ClinicalTrials.gov Identifier:	NCT00329836 History of Changes
Other Study ID Numbers:	CA/CH/01
Study First Received:	May 24, 2006
Results First Received:	July 21, 2011
Last Updated:	July 21, 2011
Health Authority:	United States: Institutional Review Board