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

A Multicenter, Open-label, Safety, Tolerability and Efficacy Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine

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.

Study Overview

• Status: Withdrawn
• Conditions: Migraine Disorders
• Intervention / Treatment: Biological: botulinum toxin Type A

• 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:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOTOX®; 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; Botulinum toxin Type A (BOTOX®) IM 155U to 195U injections in head/neck areas.; Other Names: BOTOX®; onabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Weeks 12 and 24	Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Weeks 12 and 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, Weeks 12 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 12 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 12 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): January 15, 2018
• Primary Completion (Anticipated): September 9, 2021
• Study Completion (Anticipated): September 9, 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: 1313-302-008

Drug and device information, study documents

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