Phase 1 Trial of JTM201 in Subjects With Post-stroke Uppe... | NCT07292025

NCT07292025

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
JTM201	Experimental		Drug: JTM201 in normal saline
Botox	Active Comparator		Drug: BOTOX 100U in normal saline

Name	Type	Description	Arm Group Labels	Other Names
JTM201 in normal saline	Drug	Max 360 U of Test drug IM	JTM201
BOTOX 100U in normal saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Modified Ashworth Scale score of Wrist Flexor	The Modified Ashworth Scale (MAS), a clinical scale used to assess muscle spasticity, was administered with the subject placed in a supine position. The investigator performing the assessment was required to be adequately trained and familiar with the MAS grading criteria, and the same evaluator was used throughout the clinical study whenever possible.	Week 4, Week 8, Week 12
Change from baseline in Modified Ashworth Scale score of Elbow Flexor, Finger Flexor	The Modified Ashworth Scale (MAS), a clinical scale used to assess muscle spasticity, was administered with the subject placed in a supine position. The investigator performing the assessment was required to be adequately trained and familiar with the MAS grading criteria, and the same evaluator was used throughout the clinical study whenever possible.	Week 4, Week 8, Week 12
Proportion of subjects with at least 1-point improvement from baseline in the Modified Ashworth Scale score for the Wrist Flexor, Elbow Flexor, Finger Flexor	The Modified Ashworth Scale (MAS), a clinical scale used to assess muscle spasticity, was administered with the subject placed in a supine position. The investigator performing the assessment was required to be adequately trained and familiar with the MAS grading criteria, and the same evaluator was used throughout the clinical study whenever possible.	Week 4, Week 8, Week 12
Changes from baseline in Disability Assessment Scale score	The Disability Assessment Scale (DAS) was evaluated by the investigator through an interview with the subject. The assessment was performed by the same investigator throughout the clinical study whenever possible to assess Hygiene, Dressing, Limb Position, and Pain.	Week 4, Week 8, Week 12
Global Assessment Scale evaluated by investigator

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects (or legal representatives) who voluntarily decided the participation of the study and provide written informed consent
Subjects ≥ 19 years of age, inclusive
Subjects who was diagnosed stroke at least 6 months prior to screening
Subjects with MAS score with the wrist flexor score ≥2 and at least one of the elbow flexor or finger flexor score ≥1
Subjects with a Disability Assessment Scale (DAS) score ≥2 in at least one functional domain, hygiene, dressing, limb position, or pain, selected as the primary treatment goal
Female subjects who are non-childbearing potential, or childbearing* subjects who are not pregnant, or breastfeeding, a negative serum pregnancy result during screening, and women and men of childbearing potential who agree to use medically acceptable contraceptive methods** or to be sexual abstinence during the study period

Exclusion Criteria:

Any medical condition that may affect neuromuscular function (eg, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
Subjects with dysphagia that, in the judgment of the investigator, may interfere with study participation
Subjects with fixed joint/muscle contracture* at the planned injection sites
Subjects with severe muscle atrophy at the planned injection sites
Subjects with skin abnormalities such as infection, skin disease, or scar at the planned injection sites
History of acute deterioration in pulmonary function within 3 months prior to screening [including but not limited to hospitalization due to asthma or COPD exacerbation, or pneumonia]
History of chemodenervation using phenol or alcohol, or surgery at the planned injection site within 24 weeks prior to screening, or scheduled for treatment or surgical intervention during the study
History of tendon lengthening of the study limb within 24 weeks prior to screening, or scheduled surgical intervention at the planned injection site during the study
Previous treatment with botulinum toxin of any serotype in any area within 24 weeks prior to screening
Subjects with ongoing treatment with intrathecal Baclofen
Subjects who require the administration of concomitant medications or implementation of concomitant therapies during the study period

ID	Term
D000077330	Saline Solution
D019274	Botulinum Toxins, Type A

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations