Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)

Allergan

Status and phase: Completed; Phase 4

Conditions: Chronic Migraine

Treatments: Biological: OnabotulinumtoxinA; Drug: Normal saline (placebo)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01833130

GMA-BTX-CM-12-545

Details and patient eligibility

About

This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of chronic migraine for at least 6 months prior to the screening visit
• Fifteen or more headache days during the 4-week screening period (≥4 headache episodes lasting ≥4 hours and ≥50 % of headache days are migraine)

Exclusion criteria

• Conditions causing chronic facial pain such as Temporomandibular Disorder (TMD) and fibromyalgia
• Use of headache prophylaxis medication within 4 weeks of the screening visit
• Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
• Previous use of any botulinum toxin of any serotype for any reason
• Skin infections or acne that would interfere with the injection sites
• Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, nociceptive trigeminal inhibition, occipital nerve block treatments, or injection of anesthetics/steroids within 4 weeks of screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

OnabotulinumtoxinA

Experimental group

Description:

OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.

Treatment:

Biological: OnabotulinumtoxinA

Placebo (Normal saline)

Placebo Comparator group

Description:

Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.

Treatment:

Drug: Normal saline (placebo)