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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01662492 |
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Date of registration:
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08/08/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine
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Scientific title:
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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 |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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125 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01662492 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Migraine Disorders
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Intervention(s)
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Biological: Botulinum toxin type A Dose 2
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Drug: Placebo (Normal Saline)
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Biological: Botulinum toxin type A Dose 1
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Primary Outcome(s)
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Change From Baseline in the Frequency of Headache Days
[Time Frame: Baseline, 12 Weeks]
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Secondary Outcome(s)
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Change From Baseline in the Total Cumulative Hours of Headache on Headache Days
[Time Frame: Baseline, 12 Weeks]
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Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
[Time Frame: 12 Weeks]
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Percentage of Patients With = 50% Decrease From Baseline in the Frequency of Headache Days
[Time Frame: Baseline, 12 Weeks]
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Change From Baseline in the Frequency of Severe Headache Days
[Time Frame: Baseline, 12 Weeks]
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Secondary ID(s)
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191622-103
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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