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

Phase 3WithdrawnNCT03193359

Allergan

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Conditions

Migraine Disorders

Interventions

botulinum toxin Type ABIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 24 Weeks

Percentage of Participants with AEs Leading to Discontinuation

Time frame: 24 Weeks

Change from Baseline in Vital Signs

Vital signs include blood pressure and pulse.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Week 24

Secondary Outcomes

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.

Time frame: Baseline, Weeks 12 and 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.