CompletedPhase 3

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

United States125 participantsStarted 2012-10

Plain-language 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.

Who can participate

Age range12 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline in the Frequency of Headache Days

Timeframe: Baseline, 12 Weeks

Trial details

NCT IDNCT01662492

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08

Results submitted2017-08-03

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