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

NCT03193346 | Withdrawn Phase 3

• 1 other identifier: 1313-301-008
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Frequency of Migraine/Probable Migraine Days during 28-Day Period

  Baseline, Weeks 4, 8, 12, 16, 20 and 24.

• 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 Total Cumulative Hours of Headache Days during 28-Day Period

  Baseline, Weeks 4, 8, 12, 16, 20 and 24

Study Arms (2)

BOTOX®

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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)

Interventions

botulinum toxin Type A BIOLOGICAL

Botulinum toxin Type A (BOTOX®) 155U to 195U IM injections in head/neck areas.

Also known as: BOTOX®, onabotulinumtoxinA

BOTOX®

placebo (sodium chloride 0.9 mg) DRUG

Placebo matching BOTOX® \[Sodium chloride 0.9 mg\] IM injections in head/neck areas.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Allergan: lead

Related Links

• More Information

MeSH Terms

Conditions

Migraine Disorders

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Arlene Lum

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 20, 2017
• Study Start: July 3, 2017
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: July 14, 2017

Record last verified: 2017-07