BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Participants With Chronic Migraine

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Migraine Disorders
• Intervention / Treatment: Biological: botulinum toxin Type A; Drug: placebo (sodium chloride 0.9 mg)

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOTOX®; BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections in head/neck areas at Day 0 and Week 12.	Biological: botulinum toxin Type A; Botulinum toxin Type A (BOTOX®) 155U to 195U IM injections in head/neck areas.; Other Names: BOTOX®; onabotulinumtoxinA
Placebo Comparator: Placebo; Placebo matching BOTOX® [Sodium chloride 0.9 milligrams (mg)] IM injections in head/neck areas at Day 0 and Week 12.	Drug: placebo (sodium chloride 0.9 mg); Placebo matching BOTOX® [Sodium chloride 0.9 mg] IM injections in head/neck areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Weeks 4, 8, 12, 16 and 20
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.	Baseline, Weeks 4, 8, 12, 16, 20 and 24.
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.	Baseline, Weeks 4, 8, 12, 16, 20 and 24
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.	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Arlene Lum, Allergan

Publications and helpful links

Helpful Links

• More Information

Study record dates

Study Major Dates

• Study Start (Anticipated): July 3, 2017
• Primary Completion (Anticipated): March 25, 2021
• Study Completion (Anticipated): March 25, 2021

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 1313-301-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No