A Research Study to Examine Cutaneous Allodynia and Cluster Headache - Full Text View

Sponsor:	Thomas Jefferson University
Collaborator:	Valeant Pharmaceuticals North America
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00329836

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.

Condition	Intervention	Phase
Cluster Headache	Drug: Migranal	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy 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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Dihydroergotamine Dihydroergotamine mesylate

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

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. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2006
Estimated Study Completion Date:	February 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
M open label	Drug: Migranal 4mg/ml one spray each nostril, repeat in 15 min.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329836

Contacts

Contact: Abraham A Ashkenazi, M.D.

215-955-2243

avi.ashkenazi@jefferson.edu

Locations

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

Sponsors and Collaborators

Thomas Jefferson University

Valeant Pharmaceuticals North America

Investigators

Principal Investigator:

Abraham A. Ashkenazi, M.D.

Jefferson Headache Center/ thomas Jefferson University

More Information

No publications provided

Responsible Party:	Jefferson Headache Center ( Stephen Silberstein, MD )
Study ID Numbers:	CA/CH/01, SDS/MIG-CA/01
Study First Received:	May 24, 2006
Last Updated:	January 30, 2008
ClinicalTrials.gov Identifier:	NCT00329836 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dihydroergotamine
Pain
Headache Disorders, Primary
Dopamine Agonists
Brain Diseases
Headache Disorders
Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Headache

Vasoconstrictor Agents
Analgesics
Cluster Headache
Nervous System Diseases
Central Nervous System Diseases
Cardiovascular Agents
Pharmacologic Actions
Trigeminal Autonomic Cephalalgias
Analgesics, Non-Narcotic
Neurologic Manifestations
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010