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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01662492
First received: August 8, 2012
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from baseline in the frequency of headache days [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the frequency of severe headache days [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the total cumulative hours of headache on headache days [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of patients who are prescribed oral rescue migraine prophylactic treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662492

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

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01662492     History of Changes
Other Study ID Numbers: 191622-103 
Study First Received: August 8, 2012
Last Updated: June 16, 2016
Health Authority: United States: Food and Drug Administration

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
OnabotulinumtoxinA
Botulinum Toxins, Type A
AbobotulinumtoxinA
IncobotulinumtoxinA
Botulinum Toxins
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

ClinicalTrials.gov processed this record on July 27, 2016