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

Allergan

Status and phase: Completed; Phase 3

Conditions: Migraine Disorders

Treatments: Biological: Botulinum Toxin Type A; Other: placebo (saline)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00168428

191622-080

Details and patient eligibility

About

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

Enrollment: 705 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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705 participants in 2 patient groups, including a placebo group

botulinum toxin Type A

Experimental group

Description:

Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.

Treatment:

Biological: Botulinum Toxin Type A

Placebo (saline)

Placebo Comparator group

Description:

Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.

Treatment:

Other: placebo (saline)