Back to resultsBOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Participants With Chronic Migraine
Primary Purpose
Migraine Disorders
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
botulinum toxin Type A
placebo (sodium chloride 0.9 mg)
Sponsored by
About this trial
This is an interventional prevention trial for Migraine Disorders
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BOTOX®
Placebo
Arm Description
BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections in head/neck areas at Day 0 and Week 12.
Placebo matching BOTOX® [Sodium chloride 0.9 milligrams (mg)] IM injections in head/neck areas at Day 0 and Week 12.
Outcomes
Primary Outcome Measures
Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Week 24
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Week 24. A headache day was defined as a calendar day [00:00 to 23:59] for which the participant reported ≥ 4 continuous hours of headache per patient diary.
Secondary Outcome Measures
Change from Baseline in the Frequency of Headache Days during 28-Day Period
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Weeks 4, 8, 12, 16 and 20. A headache day was defined as a calendar day [00:00 to 23:59] for which the participant reported ≥ 4 continuous hours of headache per patient diary.
Change from Baseline in the Frequency of Migraine/Probable Migraine Days during 28-Day Period
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of migraine or probable migraine episodes during the 28-day period ending with Weeks 4, 8, 12, 16, 20 and 24. A Migraine or Probable Migraine day was defined as a calendar day [00:00 to 23:59] for which the patient reported ≥ 4 continuous hours of a migraine or probable migraine episode as per the patient diary.
Change from Baseline in the Number of Moderate/Severe Headache Days during 28-Day Period
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28 day period ending with Weeks 4, 8, 12, 16, 20 and 24. A moderate/severe headache day is defined as a day (00:00 to 23:59) when a participant reported 4 or more continuous hours of headache and reported a maximum severity of moderate or severe per patient diary among all headache episodes that occurred on that day.
Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day Period
Mean change from Baseline (28-days prior to first treatment) in the total cumulative hours of headache days during the 28-day period ending with Weeks 4, 8, 12, 16, 20 and 24. A headache day is defined as a day (00:00 to 23:59) with 4 or more continuous hours of headache per patient diary.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03193346
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Corporation Decision
Study Start Date
July 3, 2017 (Anticipated)
Primary Completion Date
March 25, 2021 (Anticipated)
Study Completion Date
March 25, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOTOX®
Arm Type
Experimental
Arm Description
BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections in head/neck areas at Day 0 and Week 12.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching BOTOX® [Sodium chloride 0.9 milligrams (mg)] IM injections in head/neck areas at Day 0 and Week 12.
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A
Other Intervention Name(s)
BOTOX®, onabotulinumtoxinA
Intervention Description
Botulinum toxin Type A (BOTOX®) 155U to 195U IM injections in head/neck areas.
Intervention Type
Drug
Intervention Name(s)
placebo (sodium chloride 0.9 mg)
Intervention Description
Placebo matching BOTOX® [Sodium chloride 0.9 mg] IM injections in head/neck areas.
Primary Outcome Measure Information:
Title
Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Week 24
Description
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Week 24. A headache day was defined as a calendar day [00:00 to 23:59] for which the participant reported ≥ 4 continuous hours of headache per patient diary.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change from Baseline in the Frequency of Headache Days during 28-Day Period
Description
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Weeks 4, 8, 12, 16 and 20. A headache day was defined as a calendar day [00:00 to 23:59] for which the participant reported ≥ 4 continuous hours of headache per patient diary.
Time Frame
Baseline, Weeks 4, 8, 12, 16 and 20
Title
Change from Baseline in the Frequency of Migraine/Probable Migraine Days during 28-Day Period
Description
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of migraine or probable migraine episodes during the 28-day period ending with Weeks 4, 8, 12, 16, 20 and 24. A Migraine or Probable Migraine day was defined as a calendar day [00:00 to 23:59] for which the patient reported ≥ 4 continuous hours of a migraine or probable migraine episode as per the patient diary.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20 and 24.
Title
Change from Baseline in the Number of Moderate/Severe Headache Days during 28-Day Period
Description
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28 day period ending with Weeks 4, 8, 12, 16, 20 and 24. A moderate/severe headache day is defined as a day (00:00 to 23:59) when a participant reported 4 or more continuous hours of headache and reported a maximum severity of moderate or severe per patient diary among all headache episodes that occurred on that day.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Title
Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day Period
Description
Mean change from Baseline (28-days prior to first treatment) in the total cumulative hours of headache days during the 28-day period ending with Weeks 4, 8, 12, 16, 20 and 24. A headache day is defined as a day (00:00 to 23:59) with 4 or more continuous hours of headache per patient diary.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene Lum
Organizational Affiliation
Allergan
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://allerganclinicaltrials.com
Description
More Information
Learn more about this trial
BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Participants With Chronic Migraine
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