Pilot Study of BOTOX for Migraine Headaches

This study is currently recruiting participants.

Verified by Park Nicollet Institute, September 2009

First Received: February 23, 2009 Last Updated: September 17, 2009 History of Changes

Sponsor:	Park Nicollet Institute
Collaborator:	Allergan
Information provided by:	Park Nicollet Institute
ClinicalTrials.gov Identifier:	NCT00850421

Purpose

The purposes of this study are to assess whether subjects treated with BOTOX will:

have a decrease in the frequency and intensity of migraine headaches
experience improvements in quality of life
experience a reduction in the frequency of health care services obtained.

Condition	Intervention
Migraine Headache	Drug: Botulinum Toxin Type A

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single-Center Pharmacoeconomic Pilot Study of BOTOX® (Botulinum Toxin Type A) for the Prophylactic Treatment of Migraine Headaches

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Botox Headache Migraine

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Park Nicollet Institute:

Estimated Enrollment:	50
Study Start Date:	April 2004
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Intervention Details:

100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects > 18 years of age
Subject has an established history of migraine headache, with or without aura, per IHS criteria (1.2.1 or 1.1), for at least 6 months prior to screening.
Subject receives primary health care from Park Nicollet Health Services.

Exclusion Criteria:

Subject has received previous injections of botulinum toxin of any serotype for any reason, within the 6 months prior to study participation.

Additional eligibility will be discussed at point of contact

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850421

Contacts

Contact: Dianna Martin, RN

(952)993-3062

Locations

United States, Minnesota
Park Nicollet Health Services	Recruiting
Minneapolis, Minnesota, United States, 55426
Principal Investigator: Frederick Taylor, MD

Sponsors and Collaborators

Park Nicollet Institute

Allergan

Investigators

Principal Investigator:

Frederick Taylor, MD

Park Nicollet Health Services

More Information

No publications provided

Responsible Party:	Park Nicollet Health Services Department of Neurology ( Frederick Taylor, MD )
Study ID Numbers:	01837-04-C
Study First Received:	February 23, 2009
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00850421 History of Changes
Health Authority:	United States: Park Nicollet Institute Institutional Review Board

Keywords provided by Park Nicollet Institute:

migraine headache
Botulinum Toxin Type A
BOTOX
BTX-A

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Pain
Headache Disorders, Primary
Neuromuscular Agents
Brain Diseases
Pharmacologic Actions
Headache Disorders

Signs and Symptoms
Botulinum Toxins
Migraine Disorders
Therapeutic Uses
Headache
Neurologic Manifestations
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010