Lanzhou Institute of Biological Products Co., Ltd — Biomedical Watch V2

Traitements2programmes

Essais1liés

Publications6liées

SourceDBlocale

Traitements

2

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Botulinum Toxin Type A for InjectionThis is a multicenter, double-blind, randomized, placebo-controlled study designed to compare Botulinum Toxin Type A for Injection (HengLi®) with placebo on the efficacy and safety of treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb spasticity. Approximately 180 subjects will be enrolled. The core period of the subjects will receive a single treatment session of intramuscular HengLi® 200U or 240U (if thumb spasticity is present) or placebo in a randomization ratio of 2:1. Research contains two parts: core phase and extension phase. In the core phase, subjects will finish 6 visits (12 weeks ) after initial injection. During the extension phase, subjects will accept two follow-up visit (6 weeks). Outcome measures include changes from baseline at every post injection visit as measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global Assessment Scale(GAS). The primary efficacy endpoint is the change from baseline at week 6 for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters will also be measured including adverse events, vital signs (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and urinanalysis).	Myopathies	Phase 3	Traitement symptomatique		À vérifier
Botulinum Toxin Type A for InjectionThis is a multicenter, double-blind, randomized, placebo-controlled study designed to compare Botulinum Toxin Type A for Injection (HengLi®) with placebo on the efficacy and safety of treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb spasticity. Approximately 180 subjects will be enrolled. The core period of the subjects will receive a single treatment session of intramuscular HengLi® 200U or 240U (if thumb spasticity is present) or placebo in a randomization ratio of 2:1. Research contains two parts: core phase and extension phase. In the core phase, subjects will finish 6 visits (12 weeks ) after initial injection. During the extension phase, subjects will accept two follow-up visit (6 weeks). Outcome measures include changes from baseline at every post injection visit as measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global Assessment Scale(GAS). The primary efficacy endpoint is the change from baseline at week 6 for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters will also be measured including adverse events, vital signs (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and urinanalysis).	Myopathies	Phase 3	Traitement symptomatique		À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
Botulinum Toxin Type A for Injection	Myopathies	Phase 3	NCT02280083	A Study to Evaluate the Botulinum Toxin Type A for Injection(HengLi®) in Subjects With Post-stroke Upper Limb Spasticity	COMPLETED

Publications

6

Molécule	Indication / population	Titre	Journal	Date
Botulinum Toxin Type A for Injection		Efficacy and durability of therapies for neurogenic lower urinary tract dysfunction: A network meta-analysis of Botulinum Toxin a, instillations, and neuromodulation.	Toxicon : official journal of the International Society on Toxinology
Botulinum Toxin Type A for Injection		Comparative efficacy of intralesional therapies for keloid scars: a network meta-analysis.	Annals of medicine
Botulinum Toxin Type A for Injection		Botulinum Neurotoxin for Postoperative Facial Nerve Paralysis: A Technical Note.	Neurology India
Botulinum Toxin Type A for Injection		A retrospective study of intravesical botulin toxin type A in children with refractory detrusor overactivity.	Scientific reports
Botulinum Toxin Type A for Injection		Analyzing the Effect of Extracorporeal Shockwave Therapy after Botulinum Toxin Injection on Calf Muscle Spasticity Improvement in Patients with Multiple Sclerosis - A Randomized Clinical Trial.	Advanced biomedical research
Botulinum Toxin Type A for Injection		Cellular Remodeling of Skeletal Muscle Following Botulinum Toxin A Injection: A Single-Nucleus RNA Sequencing Study.	Aesthetic plastic surgery