Conditions: Migraine Disorders
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 125
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Botulinum toxin type A Dose 1 intramuscular injections into specified muscles. arm 2: Botulinum toxin type A Dose 2 intramuscular injections into specified muscles. arm 3: Placebo (Normal Saline) intramuscular injections into specified muscles.

Interventions: intervention 1: Botulinum toxin type A Dose 1 intervention 2: Botulinum toxin type A Dose 2 intervention 3: Placebo (Normal Saline)
Intervention descriptions: intervention 1: Botulinum toxin type A Dose 1 intramuscular injections into specified muscles. intervention 2: Botulinum toxin type A Dose 2 intramuscular injections into specified muscles. intervention 3: Placebo (Normal Saline) intramuscular injections into specified muscles.

Protocol document: