A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine

Allergan

Status and phase: Completed; Phase 3

Conditions: Migraine Disorders

Treatments: Drug: Placebo (Normal Saline); Biological: Botulinum toxin type A Dose 2; Biological: Botulinum toxin type A Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01662492

191622-103

Details and patient eligibility

About

To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.

Enrollment: 125 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medical history of chronic migraine for at least 6 months
• 15 or more headache days during a 4 week period

Exclusion criteria

• Previous use of any botulinum toxin of any serotype for any reason
• Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
• Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week -4 screening visit
• Use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 3 patient groups, including a placebo group

Botulinum toxin type A Dose 1

Experimental group

Description:

Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.

Treatment:

Biological: Botulinum toxin type A Dose 1

Botulinum toxin type A Dose 2

Experimental group

Description:

Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.

Treatment:

Biological: Botulinum toxin type A Dose 2

Placebo (Normal Saline)

Placebo Comparator group

Description:

Placebo (Normal Saline) intramuscular injections into specified muscles.

Treatment:

Drug: Placebo (Normal Saline)