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

• Status: Not yet recruiting
• Trial end date: 2022-11-28
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CKD Bio Corporation

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.