Clinical trial NCT03193346: BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Participants With Chronic Migraine
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Migraine Disorders
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the efficacy and safety of BOTOX® (Botulinum Toxin Type A) compared with placebo as headache prophylaxis in Chinese participants with chronic migraine.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic migraine prior to the baseline phase based on the revised criteria for chronic migraine listed in International Classification of Headache Disorders (ICHD)-3 beta (2013)
* 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 diagnosed with any of the following headache disorders: Familial hemiplegic migraine, Sporadic hemiplegic migraine, Migraine with brainstem aura, Migrainous infarction, Chronic tension-type headache, Hypnic headache, Hemicrania continua, New daily-persistent headache and Recurrent painful ophthalmoplegic neuropathy
* 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).

Primary outcomes:
measure: Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change from Baseline in the Frequency of Headache Days during 28-Day Period
timeFrame: Baseline, Weeks 4, 8, 12, 16 and 20
measure: Change from Baseline in the Frequency of Migraine/Probable Migraine Days during 28-Day Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24.
measure: Change from Baseline in the Number of Moderate/Severe Headache Days during 28-Day Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
Other outcomes:
Locations:
Study officials:
affiliation: Allergan
name: Arlene Lum
role: STUDY_DIRECTOR
References: