drugset
drugset / Trial / NCT03517319

Dose-response Relationship of Botullinum Toxin (DWP 450) for Finger Flexor Spasticity

NCT03517319 ↗

Phase 4 Unknown 78 enrolled Seoul National University Hospital Daewoong Pharmaceutical Co. LTD. · collab
RandomizedSingle-groupSingle-blindTreatment

Summary

Study Design: Randomized Single Blind Study Objective: To determine the dose relationship of DWP 450 for finger flexor spasticity Subjects: 78 patients with upper extremity spasticity after CVA Inclusion criteria: Patient who have spasticity (MAS greater than 2 in finger flexors) Methods: Patients will be randomly assigned to one of 5 groups. Gp 1: placebo, Gp 2: 15U, Gp 3: 30 U, Gp 4: 50 U, Gp 5: 75 U

Timeline

Start
2016-09-01
Primary completion
2018-05
Completion
2018-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Clostridium Botulinum Toxin Type A Unknown 15 iu Intramuscular
Subject Clostridium Botulinum Toxin Type A Unknown 30 iu Intramuscular
Subject Clostridium Botulinum Toxin Type A Unknown 50 iu Intramuscular
Subject Clostridium Botulinum Toxin Type A Unknown 70 iu Intramuscular

Indications

stroke disorder