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

Allergan0 sitesJuly 3, 2017

ConditionsMigraine Disorders

Interventionsbotulinum toxin Type A placebo (sodium chloride 0.9 mg)

Drugsplacebo (sodium chloride 0.9 mg)

Overview

Phase: Phase 3
Intervention: botulinum toxin Type A
Conditions: Migraine Disorders
Sponsor: Allergan
Primary Endpoint: Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Week 24
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 3, 2017

End Date

March 25, 2021

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

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

Arms & Interventions

BOTOX®

BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections in head/neck areas at Day 0 and Week 12.

Intervention: botulinum toxin Type A

Placebo

Placebo matching BOTOX® \[Sodium chloride 0.9 milligrams (mg)\] IM injections in head/neck areas at Day 0 and Week 12.

Intervention: placebo (sodium chloride 0.9 mg)

Outcomes

Primary Outcomes

Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Week 24

Time Frame: Baseline, 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 Outcomes

Change from Baseline in the Frequency of Headache Days during 28-Day Period(Baseline, Weeks 4, 8, 12, 16 and 20)
Change from Baseline in the Number of Moderate/Severe Headache Days during 28-Day Period(Baseline, Weeks 4, 8, 12, 16, 20 and 24)
Change from Baseline in the Frequency of Migraine/Probable Migraine Days during 28-Day Period(Baseline, Weeks 4, 8, 12, 16, 20 and 24.)
Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day Period(Baseline, Weeks 4, 8, 12, 16, 20 and 24)