Post-stroke Upper Limb Spasticity
Conditions
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
Sponsors
CKD Bio Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | up to week 12 | severity and frequency of reported adverse events |
Countries
South Korea
Outcome results
None listed