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


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This study is not yet open for participant recruitment.

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Verified June 2017 by Allergan

Sponsor:

Information provided by (Responsible Party):

Allergan

ClinicalTrials.gov Identifier:

NCT03193359

First received: June 19, 2017

Last updated: June 19, 2017

Last verified: June 2017

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.

Migraine Disorders Biological: botulinum toxin Type A Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: A Multicenter, Open-label, Safety, Tolerability and Efficacy Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine

Primary Outcome Measures:

  • Number of Participants with Adverse Events (AEs) [ Time Frame: 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.

  • Percentage of Participants with AEs Leading to Discontinuation [ Time Frame: 24 Weeks ]
  • Change from Baseline in Vital Signs [ Time Frame: Baseline, Week 24 ]

    Vital signs include blood pressure and pulse.

  • Change from Baseline in 12-Lead Electrocardiograms (ECGs) Parameters [ Time Frame: Baseline, Week 24 ]

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

  • Change from Baseline in Clinical Laboratory Parameters [ Time Frame: 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:

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

  • Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day period [ Time Frame: 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.

Estimated Enrollment: 595
Anticipated Study Start Date: January 15, 2018
Estimated Study Completion Date: September 9, 2021
Estimated Primary Completion Date: September 9, 2021 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03193359

Allergan

Study Director: Arlene Lum Allergan

Additional Information:

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03193359     History of Changes
Other Study ID Numbers: 1313-302-008
Study First Received: June 19, 2017
Last Updated: June 19, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
incobotulinumtoxinA
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 20, 2017