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

This study is currently recruiting participants.
Verified April 2014 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01662492
First received: August 8, 2012
Last updated: April 9, 2014
Last verified: April 2014
  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

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: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662492

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
United States, California
Recruiting
Oceanside, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01662492     History of Changes
Other Study ID Numbers: 191622-103
Study First Received: August 8, 2012
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014