Pilot Study of BOTOX for Migraine Headaches
Information source: Park Nicollet Institute
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Headache
Intervention: Botulinum Toxin Type A (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Park Nicollet Institute Official(s) and/or principal investigator(s): Frederick Taylor, MD, Principal Investigator, Affiliation: Park Nicollet Health Services
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.
Clinical Details
Official title: A Single-Center Pharmacoeconomic Pilot Study of BOTOX® (Botulinum Toxin Type A) for the Prophylactic Treatment of Migraine Headaches
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
Secondary outcome: To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Park Nicollet Health Services, Minneapolis, Minnesota 55426, United States
Additional Information
Starting date: April 2004
Last updated: July 10, 2013
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