Pilot Study of BOTOX for Migraine Headaches
Information source: Park Nicollet Institute
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Headache
Intervention: Botulinum Toxin Type A (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Park Nicollet Institute Official(s) and/or principal investigator(s):
Frederick Taylor, MD, Principal Investigator, Affiliation: Park Nicollet Health Services
Overall contact:
Dianna Martin, RN, Phone: (952)993-3062
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: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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
Dianna Martin, RN, Phone: (952)993-3062
Park Nicollet Health Services, Minneapolis, Minnesota 55426, United States; Recruiting
Frederick Taylor, MD, Principal Investigator
Additional Information
Starting date: April 2004
Ending date: February 2011
Last updated: September 17, 2009
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