Upper Limb Spasticity (ULS)
Conditions
Brief summary
This is a phase III clinical study to evaluate the efficacy and safety of recombinant botulinum toxin type A（Eveotox）in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of Eveotox compared with placebo in adult patients with upper limb spasticity.
Interventions
DRUGRecombinant Botulinum Toxin Type A for injection
Recombinant Botulinum Toxin Type A for injection
DRUGPlacebo
Placebo will be administered in double-blind fashion during treatment cycle 1 only
Sponsors
JHM BioPharma (Tonghua) Co. , Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent * Participants with stable post-stroke Spasticity (ULS) for at least 3 months * Participants with Modified Ashworth Scale (MAS) score of at least 2 at elbow flexor or wrist flexor or finger flexor * Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain) * Participants who have been stable for at least 1 month prior to study entry in terms of oral antispasticity
Exclusion criteria
* Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study. * History of alcohol or drug abuse. * Known allergy or hypersensitivity to any component of the study products. * History of epilepsy * Known or suspected to be HIV positive, serologically positive for syphilis, or active hepatitis B or C * Any medical condition that may put the participant at increased risk for botulinum toxin type A use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | Within 4 weeks | Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measure | Within 52 weeks | Incidence of adverse events and drug-related adverse events during the study. |
Countries
China
Contacts
CONTACTDanhua Lin
CONTACTLei Wang
Outcome results
None listed