Trial | NCT00850421  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Study Participants

    35
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.
Study Started
Apr 30
2004
Primary Completion
Apr 30
2010
Study Completion
Apr 30
2010
Results Posted
Sep 18
2013
Estimate
Last Update
Sep 26
2018

Drug Botulinum Toxin Type A

100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)

  • Other names: BOTOX

Botulinum Toxin Type A Other

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

Summary

Botulinum Toxin Type A

All Events

Event Type Organ System Event Term Botulinum Toxin Type A

To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.

Botulinum Toxin Type A

To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.

Botulinum Toxin Type A

To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.

Botulinum Toxin Type A

Age, Categorical

Sex: Female, Male

Overall Study

Botulinum Toxin Type A