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

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ClinicalTrials.gov Identifier: NCT01662492
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : September 5, 2017
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Biological: Botulinum toxin type A Dose 1 Biological: Botulinum toxin type A Dose 2 Drug: Placebo (Normal Saline) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Biological: Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Other Names:
  • onabotulinumtoxinA
  • BOTOX®
Experimental: Botulinum toxin type A Dose 2
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Biological: Botulinum toxin type A Dose 2
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Other Names:
  • onabotulinumtoxinA
  • BOTOX®
Placebo Comparator: Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.
Drug: Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662492


  Show 22 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01662492     History of Changes
Other Study ID Numbers: 191622-103
First Posted: August 10, 2012    Key Record Dates
Results First Posted: September 5, 2017
Last Update Posted: September 5, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents