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):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
First received: February 23, 2009
Last updated: July 10, 2013
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 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)
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
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
Park Nicollet Institute
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
Results First Received: July 10, 2013
Last Updated: July 10, 2013
Health Authority: United States: Park Nicollet Institute Institutional Review Board

Keywords provided by Park Nicollet Institute:
migraine headache
Botulinum Toxin Type A

Additional relevant MeSH terms:
Migraine Disorders
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 April 21, 2014