search
Back to results

Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb Spasticity

Primary Purpose

Post-stroke Upper Limb Spasticity

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKDB-501A
Botox®
Sponsored by
CKD Bio Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Upper Limb Spasticity

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients ≥ 19 years
  • History of stroke more than 24 weeks prior to screening
  • ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of finger flexor and elbow flexor as measured on MAS(0 to 4)
  • ≥ 2 points in one of the targeted functional disability item (i.e. hand hygiene, clothing, upper extremity, or pain for evaluation on DAS

Exclusion Criteria:

  • Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
  • Fixed joint/muscle contracture in the target limb
  • History(within 24 weeks of screening visit) or planned(during study period) treatment with phenol or alcohol injection(chemodenervation) or surgery in the target limb
  • History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
  • History(within 12 weeks of screening visit) treatment with Botulinum Toxin
  • Concurrent treatment with an intrathecal baclofen
  • Known allergy or sensitivity to the study medication or its components (Clostridium botulinum toxin type A, albumin, Sodium chloride, etc.)
  • Male and Female who are not willing to take any appropriate means of contraception during the study period
  • Patients who are not eligible for this study at the discretion of the investigator.

Sites / Locations

  • Seoul National University Hospital
  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CKDB-501A

Botox®

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Adverse Events
severity and frequency of reported adverse events

Secondary Outcome Measures

Full Information

First Posted
May 16, 2022
Last Updated
March 27, 2023
Sponsor
CKD Bio Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT05382767
Brief Title
Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb Spasticity
Official Title
A Randomized, Double-blind, Active-controlled, Multicenter Phase I Trial to Investigate the Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
December 8, 2022 (Actual)
Study Completion Date
December 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CKD Bio Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Multicenter, randomized, double-blind, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Subjects with Post-stroke Upper Limb Spasticity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Upper Limb Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CKDB-501A
Arm Type
Experimental
Arm Title
Botox®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CKDB-501A
Intervention Description
Muscle Spasticity
Intervention Type
Drug
Intervention Name(s)
Botox®
Intervention Description
Muscle Spasticity
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
severity and frequency of reported adverse events
Time Frame
up to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients ≥ 19 years History of stroke more than 24 weeks prior to screening ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of finger flexor and elbow flexor as measured on MAS(0 to 4) ≥ 2 points in one of the targeted functional disability item (i.e. hand hygiene, clothing, upper extremity, or pain for evaluation on DAS Exclusion Criteria: Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis Fixed joint/muscle contracture in the target limb History(within 24 weeks of screening visit) or planned(during study period) treatment with phenol or alcohol injection(chemodenervation) or surgery in the target limb History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb History(within 12 weeks of screening visit) treatment with Botulinum Toxin Concurrent treatment with an intrathecal baclofen Known allergy or sensitivity to the study medication or its components (Clostridium botulinum toxin type A, albumin, Sodium chloride, etc.) Male and Female who are not willing to take any appropriate means of contraception during the study period Patients who are not eligible for this study at the discretion of the investigator.
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb Spasticity

We'll reach out to this number within 24 hrs