Pilot Study of BOTOX for Migraine Headaches - Tabular View

Tracking Information

First Received Date ^ICMJE

February 23, 2009

Last Updated Date

September 17, 2009

Start Date ^ICMJE

April 2004

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00850421 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Pilot Study of BOTOX for Migraine Headaches

Official Title ^ICMJE

A Single-Center Pharmacoeconomic Pilot Study of BOTOX® (Botulinum Toxin Type A) for the Prophylactic Treatment of Migraine Headaches

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Migraine Headache

Intervention ^ICMJE

Drug: Botulinum Toxin Type A

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

Other Name: BOTOX

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2011

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dianna Martin, RN

(952)993-3062

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00850421

Responsible Party

Frederick Taylor, MD, Park Nicollet Health Services Department of Neurology

Study ID Numbers ^ICMJE

01837-04-C

Study Sponsor ^ICMJE

Park Nicollet Institute

Collaborators ^ICMJE

Allergan

Investigators ^ICMJE

Principal Investigator:

Frederick Taylor, MD

Park Nicollet Health Services

Information Provided By

Park Nicollet Institute

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP