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

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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

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)

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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