A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity

An Open-label, Multicenter Clinical Study on The Long-term Safety and Efficacy of Multiple Treatments With Recombinant Botulinum Toxin Type A (YY001) for Injection in Adult Upper Limb Spasticity (REHAB-2)

This is an open-label, multicenter, phase III clinical study to evaluate the long-term safety and efficacy of multiple treatments with recombinant botulinum toxin type A (YY001) for injection in adult upper limb spasticity

Inclusion Criteria:

1. Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
2. Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to enrollment) exhibiting upper limb spasticity.
3. Subjects with Disability Assessment Scale score of at least 2 on the Principal Target of Treatment (one of four functional domains: hygiene, dressing, limb position and pain).

Exclusion Criteria:

1. History of allergy to any component of the experimental drugs.
2. Previous use of any botulinum toxin within 6 months prior to enrollment, or plan to use other botulinum toxins not specified in the study protocol during the study.
3. Fixed contractures of the studied limb.
4. Any medical condition that may increase the risk to the subject when using botulinum toxin type A.
5. Need for treatment with drugs that interfere with neuromuscular function during the study.
6. Plan or anticipate to use new antispasticity drugs during the study.
7. History of epilepsy.
8. Pregnant or breastfeeding women.
9. Participation in other drug/device clinical trials within 1 month prior to enrollment.