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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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

Last updated:

4/9/2014

NCT ID:

NCT01662492

IRB Number:

12-009297