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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-02

Study Completion Date

2022-12-08

Brief Summary

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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

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Detailed Description

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Conditions

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Post-stroke Upper Limb Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CKDB-501A

Group Type EXPERIMENTAL

CKDB-501A

Intervention Type DRUG

Muscle Spasticity

Botox®

Group Type ACTIVE_COMPARATOR

Botox®

Intervention Type DRUG

Muscle Spasticity

Interventions

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CKDB-501A

Muscle Spasticity

Intervention Type DRUG

Botox®

Muscle Spasticity

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No