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

Post-stroke Upper Limb Spasticity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05382767
• Other study ID #: CKDB-BAUL-101
• Status: Completed
• Phase: Phase 1
• Start date: June 2, 2022
• Est. completion date: December 8, 2022

Study information

• Verified date: March 2023
• Source: CKD Bio Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Post-stroke Upper Limb Spasticity
• Stroke

Intervention

Drug:
• CKDB-501A
Muscle Spasticity
• Botox®
Muscle Spasticity

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CKD Bio Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	severity and frequency of reported adverse events	up to week 12