Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04582929
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2020-10-05
Brief Title:
Neubotulinum Toxin Injection in Cerivical Dystonia
Sponsor:
Rajavithi Hospital
Organization:
Rajavithi Hospital
Study Overview
Official Title:
24-Week Prospective Double-Blinded Randomized Cross-over Design in Multicenter Study of 50 Unit of Neubotulinum Toxin Type A Neuronox and 100 Unit of Neubotulinum Toxin Type A Neuronox Injection for Cervical Dystonia in Thai Patients
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NTCD
Brief Summary:
24-Week Prospective Double-Blinded Randomized Cross-over design in Multicenter Study of 50 unit of Neubotulinum Toxin Type A Neuronox and 100 unit of Neubotulinum Toxin Type A Neuronox injection for Cervical Dystonia in patient diagnosed with cervical dystonia according to clinical diagnosis It was designed to evaluate the efficacy safety tolerability quality of life and the comparesion the improvement after treatment by of 50 unit of Neubotulinum Toxin Type A Neuronox and 100 unit of Neubotulinum Toxin Type A Neuronox injection
Detailed Description:
Three documented studies showed the clinical use of botulinum toxin for migraine prophylaxis26 Neubotulinum Toxin Type A Neu-BoNTA Neuronox Medytox Inc Ochang-eup Cheongwon-gu Cheongju-si Chungcheongbuk-do Republic of Korea also known as Meditoxin in Korea is a newly manufactured BoNT-A Neu-BoNTA that was developed to provide features close to onabotulinum toxin A 5 Neuronox was tested in a murine model and its effect on muscle force generation was equivalent to Botox ona-BoNTA 6 A previous multicenter randomized controlled trial showed that Neuronox and Botox have equivalent efficacy and safety for the treatment of spastic equinus in children with cerebral palsy 6 However 50 unit of Neubotulinum Toxin Type A Neuronox and 100 unit of Neubotulinum Toxin Type A Neuronox has not yet been investigated in cervical dystonia This study is the extension of the NCT03805152
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None