Pilot Study of BOTOX for Migraine Headaches

This study has been terminated.

( Recently published BOTOX efficacy data and study design deficits. )

First Received on February 23, 2009. Last Updated on August 29, 2011 History of Changes

Sponsor:	Park Nicollet Institute
Collaborator:	Allergan
Information provided by (Responsible Party):	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:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:

To determine whether resource utilization is decreased in subjects treated with BOTOX injections for episodic migraine headache. [ Time Frame: 190 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine whether quality of life is improved in subjects treated with BOTOX injections for episodic migraine headache. [ Time Frame: 190 days ] [ Designated as safety issue: No ]
To assess the effect of BOTX injections on the frequency and intensity of migraine episodes in subjects with episodic migraine headache. [ Time Frame: 190 days ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	April 2004
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Name: BOTOX

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

Locations

United States, Minnesota
Park Nicollet Health Services
Minneapolis, Minnesota, United States, 55426

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 Institute
ClinicalTrials.gov Identifier:	NCT00850421 History of Changes
Other Study ID Numbers:	01837-04-C
Study First Received:	February 23, 2009
Last Updated:	August 29, 2011
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:

Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012