Status:
COMPLETED
Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb Spasticity
Lead Sponsor:
CKD Bio Corporation
Conditions:
Post-stroke Upper Limb Spasticity
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05382767
Start Date
June 2 2022
End Date
December 8 2022
Last Update
March 28 2023
Active Locations (2)
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1
Seoul National University Hospital
Seoul, South Korea
2
SMG-SNU Boramae Medical Center
Seoul, South Korea