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NCT00850421 Clinical Trial

Pilot Study of BOTOX for Migraine Headaches

Migraine Headache Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00850421
Other study ID # 01837-04-C
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 2004
Est. completion date April 2010

Study information
Verified date July 2013
Source HealthPartners Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 35
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Botulinum Toxin Type A
100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)

Locations
Country Name City State
United States Park Nicollet Health Services Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
HealthPartners Institute Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. 190 days
Secondary To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. 190 days
Secondary To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache. 190 days
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