Pilot Study of BOTOX for Migraine Headaches

This study has been terminated.
(Recently published BOTOX efficacy data and study design deficits.)
Information provided by (Responsible Party):
HealthPartners Institute
ClinicalTrials.gov Identifier:
First received: February 23, 2009
Last updated: November 25, 2015
Last verified: July 2013

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

  1. have a decrease in the frequency and intensity of migraine headaches
  2. experience improvements in quality of life
  3. 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:

Further study details as provided by HealthPartners 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)
Arms Assigned Interventions
Botulinum Toxin Type A Drug: Botulinum Toxin Type A
100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)
Other Name: BOTOX


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

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

United States, Minnesota
Park Nicollet Health Services
Minneapolis, Minnesota, United States, 55426
Sponsors and Collaborators
HealthPartners Institute
Principal Investigator: Frederick Taylor, MD Park Nicollet Health Services
  More Information

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT00850421     History of Changes
Other Study ID Numbers: 01837-04-C 
Study First Received: February 23, 2009
Results First Received: July 10, 2013
Last Updated: November 25, 2015
Health Authority: United States: Park Nicollet Institute Institutional Review Board

Keywords provided by HealthPartners Institute:
migraine headache
Botulinum Toxin Type A

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Cholinergic Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016