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Completed

NCT Number: NCT01662492

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

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A Dose 1

Biological

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

Other names: onabotulinumtoxinA, BOTOX®

Botulinum toxin type A Dose 2

Biological

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

Other names: onabotulinumtoxinA, BOTOX®

Placebo (normal saline)

Drug

Placebo (Normal Saline) intramuscular injections into specified muscles.

Primary outcomes

  1. Change From Baseline in the Frequency of Headache Days

    Time frame: Baseline, 12 Weeks

    Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.

Secondary outcomes

  1. Change From Baseline in the Frequency of Severe Headache Days

    Time frame: Baseline, 12 Weeks

    Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.

  2. Change From Baseline in the Total Cumulative Hours of Headache on Headache Days

    Time frame: Baseline, 12 Weeks

    Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.

  3. Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days

    Time frame: Baseline, 12 Weeks

    Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.

  4. Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment

    Time frame: 12 Weeks

    Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

191622-103 BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Adolescents (Children 12 to < 18 Years of Age) With Chronic Migraine

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 10, 2012
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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