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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 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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]
  • 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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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 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

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

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on September 20, 2017