Back to resultsOpen Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
Primary Purpose
Migraine Disorders
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
botulinum toxin Type A
Sponsored by
About this trial
This is an interventional prevention trial for Migraine Disorders
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BOTOX®
Arm Description
BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections to head/neck areas at Day 0 and Week 12.
Outcomes
Primary Outcome Measures
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.
Percentage of Participants with AEs Leading to Discontinuation
Change from Baseline in Vital Signs
Vital signs include blood pressure and pulse.
Change from Baseline in 12-Lead Electrocardiograms (ECGs) Parameters
A standard 12-lead ECG will be performed at Baseline and 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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03193359
Brief Title
Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Corporate Decision
Study Start Date
January 15, 2018 (Anticipated)
Primary Completion Date
September 9, 2021 (Anticipated)
Study Completion Date
September 9, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOTOX®
Arm Type
Experimental
Arm Description
BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections to head/neck areas at Day 0 and Week 12.
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A
Other Intervention Name(s)
BOTOX®, onabotulinumtoxinA
Intervention Description
Botulinum toxin Type A (BOTOX®) IM 155U to 195U injections in head/neck areas.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs)
Description
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
Title
Percentage of Participants with AEs Leading to Discontinuation
Time Frame
24 Weeks
Title
Change from Baseline in Vital Signs
Description
Vital signs include blood pressure and pulse.
Time Frame
Baseline, Week 24
Title
Change from Baseline in 12-Lead Electrocardiograms (ECGs) Parameters
Description
A standard 12-lead ECG will be performed at Baseline and Week 24.
Time Frame
Baseline, Week 24
Title
Change from Baseline in Clinical Laboratory Parameters
Description
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 Outcome Measure Information:
Title
Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Weeks 12 and 24
Description
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
Title
Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day period
Description
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.
Time Frame
Baseline, Weeks 12 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene Lum
Organizational Affiliation
Allergan
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://allerganclinicaltrials.com
Description
More Information
Learn more about this trial
Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
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