Back to resultsPilot Study of BOTOX for Migraine Headaches
Primary Purpose
Migraine Headache
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Headache focused on measuring migraine headache, Botulinum Toxin Type A, BOTOX, BTX-A
Eligibility 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
Sites / Locations
- Park Nicollet Health Services
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Botulinum Toxin Type A
Arm Description
Outcomes
Primary Outcome Measures
To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00850421
First Posted
February 23, 2009
Last Updated
August 28, 2018
Sponsor
HealthPartners Institute
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT00850421
Brief Title
Pilot Study of BOTOX for Migraine Headaches
Official Title
A Single-Center Pharmacoeconomic Pilot Study of BOTOX® (Botulinum Toxin Type A) for the Prophylactic Treatment of Migraine Headaches
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Why Stopped
Recently published BOTOX efficacy data and study design deficits.
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purposes of this study are to assess whether subjects treated with BOTOX will:
have a decrease in the frequency and intensity of migraine headaches
experience improvements in quality of life
experience a reduction in the frequency of health care services obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
migraine headache, Botulinum Toxin Type A, BOTOX, BTX-A
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulinum Toxin Type A
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
BOTOX
Intervention Description
100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)
Primary Outcome Measure Information:
Title
To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
Time Frame
190 days
Secondary Outcome Measure Information:
Title
To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
Time Frame
190 days
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Taylor, MD
Organizational Affiliation
Park Nicollet Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Park Nicollet Health Services
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of BOTOX for Migraine Headaches
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