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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

Page last updated: August 20, 2015

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