Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
|ClinicalTrials.gov Identifier: NCT03193359|
Recruitment Status : Withdrawn (Corporate Decision)
First Posted : June 20, 2017
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Migraine Disorders||Biological: botulinum toxin Type A||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||September 9, 2021|
|Estimated Study Completion Date :||September 9, 2021|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193359
|Study Director:||Arlene Lum||Allergan|