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

NCT03517319 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2018-05-07

No results posted yet for this study

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

Conditions

  • Spasticity as Sequela of Stroke

Interventions

DRUG

Normal Saline 0.9% 1.2 ml

DRUG

Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U

DRUG

Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U

DRUG

Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U

DRUG

Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Shi-Uk Lee · Seoul National University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2018-05-31
Completion
2018-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517319 on ClinicalTrials.gov