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

• Sponsor: CKD Bio Corporation (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05382767
• Collaborator: (none)
• Enrollment: 24
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 5.7
• Patients Per Site: 12
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Post-stroke Upper Limb Spasticity	Drug: CKDB-501A; Drug: Botox®	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Active-controlled, Multicenter Phase I Trial to Investigate the Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb
• Anticipated Study Start Date: Jun 6, 2022
• Anticipated Primary Completion Date: Nov 28, 2022
• Anticipated Study Completion Date: Nov 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CKDB-501A	Drug: CKDB-501A; Muscle Spasticity
Active Comparator: Botox®	Drug: Botox®; Muscle Spasticity

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events [up to week 12]

   severity and frequency of reported adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of
2	SMG-SNU Boramae Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• CKD Bio Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CKD Bio Corporation
• ClinicalTrials.gov Identifier: NCT05382767
• Other Study ID Numbers: CKDB-BAUL-101
• First Posted: May 19, 2022
• Last Update Posted: May 19, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscle Spasticity; Stroke

Study Results

No Results Posted as of May 19, 2022