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Pilot Study of BOTOX for Migraine Headaches

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ClinicalTrials.gov Identifier: NCT00850421
Recruitment Status : Terminated (Recently published BOTOX efficacy data and study design deficits.)
First Posted : February 25, 2009
Results First Posted : September 18, 2013
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
HealthPartners Institute

Brief Summary:

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 or disease Intervention/treatment Phase
Migraine Headache Drug: Botulinum Toxin Type A Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
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
Study Start Date : April 2004
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Botulinum Toxin Type A Drug: Botulinum Toxin Type A
100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)
Other Name: BOTOX



Primary Outcome Measures :
  1. To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. [ Time Frame: 190 days ]

Secondary Outcome Measures :
  1. To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. [ Time Frame: 190 days ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850421


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

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT00850421     History of Changes
Other Study ID Numbers: 01837-04-C
First Posted: February 25, 2009    Key Record Dates
Results First Posted: September 18, 2013
Last Update Posted: October 6, 2017
Last Verified: July 2013

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

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
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