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A Research Study to Examine Cutaneous Allodynia and Cluster Headache - NCT00329836-19107(Clinical Trial 143606)



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City:  Philadelphia
State:  
PA
Zip Code: 19107
Conditions: Cluster Headache
Purpose: This is a research study examining cutaneous (q-tan-ee-us) allodynia (all-o-din-ee-uh) and cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli (e.g. light touch) are applied to the skin. Many studies have been performed looking at the presence of cutaneous allodynia in patients with migraine; however, few studies have examined it in cluster headache patients. There is still much to be learned about the brain and how it functions if we are to understand the underlying causes of cluster headache. It is important to explore cutaneous allodynia in cluster headache as it may help guide physicians with the care of these individuals.Sixty patients will be screened for this study, in order to enroll sixty subjects. Thomas Jefferson University is the only center enrolling patients in this research study.
Study summary: Cutaneous Allodynia (CA) is experience dby many migraineurs. This study is to examine the use of migranal in the acute treatment of migraine and CA. This study consists of 3 visits to the study center. All qualifying subjects will be dispensed open-label migranal. Subjects are asked to treat 2 migraines with study drug. Subjects have 6 weeks to treat each headache. Subjects will treat one headache one hour aafter the onset of throbbing pain and the other four hours after the onset of throbbing pain. After the subjects treates their first migraine with study drug they are asked to return to the study center within one week of treatment for a follow-up visit. After treatment of a second migraine subjects are asked to return within one week of treatment for a final visit.
Criteria: Inclusion Criteria: - Male and female patients aged 18-75, inclusive - Diagnosis of cluster headache, episodic or chronic. Patients with episodic CH can be either in active cluster period or not. - Ability to read and understand an informed consent form, where the study protocol is described. Exclusion Criteria: - Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc). - Patients who are cognitively impaired, as determined by investigator - Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators. - Patients who had taken an acute pain medication within 24 hours prior to allodynia testing. - Patients with skin diseases that may cause abnormal skin sensation. - Patients who had been treated with a nerve block in the 4 week period prior to allodynia testing - Patients who had been treated with Botulinum neurotoxin within the 4 month period prior to allodynia testing
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Data Source: ClinicalTrials.gov
Date Processed: November 11, 2010
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