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

Phase 1

Completed

• Conditions: Post-stroke Upper Limb Spasticity
• Interventions: Drug: CKDB-501A; Drug: Botox®

• Registration Number: NCT05382767
• Lead Sponsor: CKD Bio Corporation

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-19
• Study Start: 2022-06-02
• Primary Completion: 2022-12-08
• Study Completion: 2022-12-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKDB-501A	CKDB-501A	-
Botox®	Botox®	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	up to week 12	severity and frequency of reported adverse events

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of