Study Stopped
Recently published BOTOX efficacy data and study design deficits.
Pilot Study of BOTOX for Migraine Headaches
A Single-Center Pharmacoeconomic Pilot Study of BOTOX® (Botulinum Toxin Type A) for the Prophylactic Treatment of Migraine Headaches
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 23, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
September 18, 2013
CompletedSeptember 26, 2018
July 1, 2013
6 years
February 23, 2009
July 10, 2013
August 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
190 days
Secondary Outcomes (2)
To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
190 days
To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.
190 days
Study Arms (1)
Botulinum Toxin Type A
OTHERInterventions
100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HealthPartners Institutelead
- Allergancollaborator
Study Sites (1)
Park Nicollet Health Services
Minneapolis, Minnesota, 55426, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated and PI left organization. No results available to report
Results Point of Contact
- Title
- Park Nicollet Institute
- Organization
- Park Nicollet Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Frederick Taylor, MD
Park Nicollet Health Services
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2009
First Posted
February 25, 2009
Study Start
April 1, 2004
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
September 26, 2018
Results First Posted
September 18, 2013
Record last verified: 2013-07