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

CKD Bio

Status and phase

Completed

Phase 1

Conditions

Post-stroke Upper Limb Spasticity

Treatments

Drug: CKDB-501A

Drug: Botox®

Study type

Interventional

Funder types

Industry

Identifiers

NCT05382767

CKDB-BAUL-101

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

19+ years old

Volunteers

No 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.