A Research Study to Examine Cutaneous Allodynia and Cluster Headache

Condition(s) targeted: Cluster Headache

Intervention: Migranal (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Thomas Jefferson University

Official(s) and/or principal investigator(s):
Abraham A. Ashkenazi, M.D., Principal Investigator, Affiliation: Jefferson Headache Center/ thomas Jefferson University

Overall contact:
Abraham A Ashkenazi, M.D., Phone: 215-955-2243, Email: avi.ashkenazi@jefferson.edu

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.

Official title: An Open-Label Piolt Trial to Collect and Evaluate Data on the Use of Migranal in the Treatment of Two Acute Migraine Attacks Associated With Cutaneous Allodynia.

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: Efficacy of Migranal® in subjects who treat a migraine attack at 1-hour from onset of throbbing pain and a subsequent attack treated at 4-hours from onset of throbbing pain and presence or absence of cutaneous allodynia.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Abraham A Ashkenazi, M.D., Phone: 215-955-2243, Email: avi.ashkenazi@jefferson.edu

Jefferson Headache Center/ Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States; Recruiting
Abraham A Ashkenzai, M.D., Principal Investigator

Starting date: August 2006
Ending date: February 2008
Last updated: January 30, 2008