Verified June 2017 by Allergan
Information provided by (Responsible Party):
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 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|
- 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.
|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)|
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.
|Ages Eligible for Study:||18 Years to 65 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
-Has successfully completed the double-blind study (1313-301-008).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03193359
|Study Director:||Arlene Lum||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:
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Peripheral Nervous System Agents
ClinicalTrials.gov processed this record on June 20, 2017