Phase 1 Trial of JTM201 in Subjects With Post-stroke Upper Limb Spasticity

Jetema Co., Ltd.

Status and phase

Completed

Phase 1

Conditions

Upper Limb Spasticity Post-Stroke

Treatments

Drug: BOTOX 100U in normal saline

Drug: JTM201 in normal saline

Study type

Interventional

Funder types

Industry

Identifiers

JTM201-ULP1

Details and patient eligibility

About

Phase 1 trial to evaluate the safety and efficacy of JTM201 compared with 'Botox® Inj.' in subjects with post-stroke upper limb spasticity

Enrollment

30 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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