Post-stroke Upper Limb SpasticityPhase 1NCT05382767

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

A Phase 1 study testing CKDB-501A and Botox® in people with Post-stroke Upper Limb Spasticity, run by CKD Bio Corporation at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Post-stroke Upper Limb Spasticity
What is being tested?: CKDB-501A and Botox®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesSouth Korea
Study dates: 2 Jun 2022to 8 Dec 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

Seoul National University Hospital
Seoul
SMG-SNU Boramae Medical Center
Seoul

Other trials in South Korea

About this study

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

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

Conditions: Post-stroke Upper Limb Spasticity
Being tested: CKDB-501A, Botox®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CKDB-501ADrug
Muscle Spasticity
Botox®Drug
Muscle Spasticity

Study groups in NCT05382767
Study group	Role	What they receive
CKDB-501A	Experimental	Not described Receives: Drug: CKDB-501A
Botox®	Active comparator	Not described Receives: Drug: Botox®

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Events
severity and frequency of reported adverse events
Measured: up to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jun 20228 Dec 2022

First posted19 May 2022
Study start2 Jun 2022
Primary completion8 Dec 2022
Study completion8 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Post-stroke Upper Limb SpasticityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05382767
Sponsor's protocol ID: CKDB-BAUL-101
Status last verified: Mar 2023
First submitted: 16 May 2022
Last updated: 28 Mar 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05382767
Acronym / sponsor ID: CKDB-BAUL-101
Conditions: Post-stroke Upper Limb Spasticity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: CKD Bio CorporationIndustry (pharma, biotech, devices)
Study start: 2 Jun 2022 (actual)
Primary completion: 8 Dec 2022 (actual)
Study completion: 8 Dec 2022 (actual)
First posted: 19 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
CKDB-501A	Experimental	Drug: CKDB-501A
Botox®	Active comparator	Drug: Botox®

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CKDB-501AMuscle Spasticity	Drug	CKDB-501A
Botox®Muscle Spasticity	Drug	Botox®

Primary outcome

Incidence of Adverse Events
Time frame: up to week 12
severity and frequency of reported adverse events

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKDB-501A and Botox® in people with Post-stroke Upper Limb Spasticity, run by CKD Bio Corporation at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: up to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05382767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.