BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Participants With Chronic Migraine
NCT ID: NCT03193346
Last Updated: 2017-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2017-07-03
2021-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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BOTOX®
BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections in head/neck areas at Day 0 and Week 12.
botulinum toxin Type A
Botulinum toxin Type A (BOTOX®) 155U to 195U IM injections in head/neck areas.
Placebo
Placebo matching BOTOX® \[Sodium chloride 0.9 milligrams (mg)\] IM injections in head/neck areas at Day 0 and Week 12.
placebo (sodium chloride 0.9 mg)
Placebo matching BOTOX® \[Sodium chloride 0.9 mg\] IM injections in head/neck areas.
Interventions
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botulinum toxin Type A
Botulinum toxin Type A (BOTOX®) 155U to 195U IM injections in head/neck areas.
placebo (sodium chloride 0.9 mg)
Placebo matching BOTOX® \[Sodium chloride 0.9 mg\] IM injections in head/neck areas.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fifteen or more headache days during the 4-week baseline phase, with each day consisting of 4 or more hours of continuous headache
* Routine non-headache medications of stable dose and regimen for at least 1 month prior to the start of screening.
Exclusion Criteria
* Participants with a confirmed history of medication overuse headache
* Participants with a diagnosis of retinal migraine, persistent aura without infarction or migraine-triggered seizure
* Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
* Use of any headache prophylactic medication within 28 days prior to the start of the screening
* Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
* Participants with a known or suspected Temporomandibular Disorder (TMD), including pain in or around the Temporomandibular Joint (TMJ)
* Participants with a concurrent diagnosis of fibromyalgia
* Previous treatment with botulinum toxin therapy for any reason, or immunization to any botulinum toxin serotype
* Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, nociceptive trigeminal inhibition or occipital nerve block treatments, or injection of anesthetics or steroids into the study target muscles within 28 days prior to the start of the screening
* Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
18 Years
65 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Arlene Lum
Role: STUDY_DIRECTOR
Allergan
Related Links
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More Information
Other Identifiers
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1313-301-008
Identifier Type: -
Identifier Source: org_study_id
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