Pilot Study of BOTOX for Migraine Headaches

HealthPartners Institute

Status: Terminated

Conditions: Migraine Headache

Treatments: Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00850421

01837-04-C

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Botulinum Toxin Type A

Other group

Treatment:

Drug: Botulinum Toxin Type A