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Completed

NCT Number: NCT05382767

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

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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Key information

Conditions

Post-stroke Upper Limb Spasticity

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SMG-SNU Boramae Medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CKDB-501A

Drug

Muscle Spasticity

Botox®

Drug

Muscle Spasticity

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: up to week 12

    severity and frequency of reported adverse events

Sponsors and collaborators

Lead sponsor

CKD Bio Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 19, 2022
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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