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

Phase 3

Withdrawn

• Conditions: Migraine Disorders
• Interventions: Biological: botulinum toxin Type A

• Registration Number: NCT03193359
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-20
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-14
• Study Start: 2018-01-15
• Primary Completion: 2021-09-09
• Study Completion: 2021-09-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with AEs Leading to Discontinuation	24 Weeks
Change from Baseline in Vital Signs	Baseline, Week 24	Vital signs include blood pressure and pulse.
Change from Baseline in 12-Lead Electrocardiograms (ECGs) Parameters	Baseline, Week 24	A standard 12-lead ECG will be performed at Baseline and Week 24.
Number of Participants with Adverse Events (AEs)	24 Weeks	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.
Change from Baseline in Clinical Laboratory Parameters	Baseline, Week 24	Blood samples will be collected at Baseline and Week 24 for standard clinical laboratory testing including hematology, chemistry, urinalysis an immunogenicity parameters.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day period	Baseline, Weeks 12 and 24	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.
Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Weeks 12 and 24	Baseline, 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.