Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine

NCT03193359 | Withdrawn Phase 3

• 1 other identifier: 1313-302-008
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is an open-label extension study to evaluate the safety, tolerability and efficacy of BOTOX® as headache prophylaxis in Chinese patients with chronic migraine who have successfully completed the double-blind study: 1313-301-008.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (5)

• Number of Participants with Adverse Events (AEs)

  An AE is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

  24 Weeks

• Percentage of Participants with AEs Leading to Discontinuation

  24 Weeks

• Change from Baseline in Vital Signs

  Vital signs include blood pressure and pulse.

  Baseline, Week 24

• Change from Baseline in 12-Lead Electrocardiograms (ECGs) Parameters

  A standard 12-lead ECG will be performed at Baseline and Week 24.

  Baseline, Week 24

• Change from Baseline in Clinical Laboratory Parameters

  Blood samples will be collected at Baseline and Week 24 for standard clinical laboratory testing including hematology, chemistry, urinalysis an immunogenicity parameters.

  Baseline, Week 24

Secondary Outcomes (2)

• Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Weeks 12 and 24

  Baseline, Weeks 12 and 24

• Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day period

  Baseline, Weeks 12 and 24

Study Arms (1)

BOTOX®

EXPERIMENTAL

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

Biological: botulinum toxin Type A

Interventions

botulinum toxin Type A BIOLOGICAL

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

Also known as: BOTOX®, onabotulinumtoxinA

BOTOX®

Eligibility Criteria

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

You may qualify if:

• Has successfully completed the double-blind study (1313-301-008).

You may not qualify if:

• Has met any of the withdrawal criteria in the double-blind study or has clinical significant abnormal laboratory or electrocardiogram (ECG) findings
• Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
• 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.

Sponsors & Collaborators

• Allergan: lead

Related Links

• More Information

MeSH Terms

Conditions

Migraine Disorders

Interventions

Botulinum Toxins, Type A

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

Study Officials

• Arlene Lum

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 20, 2017
• Study Start: January 15, 2018
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: July 14, 2017

Record last verified: 2017-07