Pilot Study of BOTOX for Migraine Headaches

Not Applicable

Terminated

• Conditions: Migraine Headache
• Interventions: Drug: Botulinum Toxin Type A

• Registration Number: NCT00850421
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-23
• Study First Posted: 2009-02-25
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2013-07
• Results First Submitted: 2013-07-10
• Results First Submitted QC: 2013-07-10
• Results First Posted: 2013-09-18
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin Type A	Botulinum Toxin Type A	-

Primary Outcome Measures

Name	Time	Method
To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.	190 days

Secondary Outcome Measures

Name	Time	Method
To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.	190 days
To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.	190 days

Trial Locations

Locations (1)

Park Nicollet Health Services; 🇺🇸 Minneapolis, Minnesota, United States