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

NCT05382767 | Completed Phase 1

• 1 other identifier: CKDB-BAUL-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Conditions

Post-stroke Upper Limb Spasticity

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  severity and frequency of reported adverse events

  up to week 12

Study Arms (2)

CKDB-501A

EXPERIMENTAL

Drug: CKDB-501A

Botox®

ACTIVE COMPARATOR

Drug: Botox®

Interventions

CKDB-501A DRUG

Muscle Spasticity

CKDB-501A

Botox® DRUG

Muscle Spasticity

Botox®

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CKD Bio Corporation: lead

Study Sites (2)

Seoul National University Hospital

Seoul, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: June 2, 2022
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)