A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine Disorders

In brief

This is a 60 week study including a double-blind phase followed by an open-label phase.

Key facts

Study ID

NCT00168428

Run by

Allergan

People needed

705

Starts

2006-03-01

Expected to finish

2008-08-01

Last updated by the study team

2013-11-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Frequent migraine (>=15 headache days per month)
• >=4 distinct headache episodes lasting >=4 hours
• >=50% of baseline headache days migraine/probable migraine days

You may not qualify if…

• Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype
• Any medical condition that puts the patient at increased risk with exposure to BOTOX
• Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache
• Use of prophylactic headache medication within 28 days prior to week -4
• Unremitting headache lasting continuously throughout the 4-week baseline period
• Known or suspected TMD
• Diagnosis of fibromyalgia
• Beck depression inventory score >24 at week-4
• Psychiatric problems that may have interfered with study participation

Where it is running

• Study site — Walnut Creek, California, United States
• Study site — Calgary, Alberta, Canada
• Study site — Zagreb, Croatia
• Study site — Essen, Germany
• Study site — Zurich, Switzerland
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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