RecruitingPhase 3

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

China300 participantsStarted 2026-03-27

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
✓. Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to enrollment) exhibiting upper limb spasticity.
✓. 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

✕. History of allergy to any component of the experimental drugs.
✕. 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.
✕. Fixed contractures of the studied limb.
✕. Any medical condition that may increase the risk to the subject when using botulinum toxin type A.
✕. Need for treatment with drugs that interfere with neuromuscular function during the study.
✕. Plan or anticipate to use new antispasticity drugs during the study.
✕. History of epilepsy.
✕. Pregnant or breastfeeding women.

What they're measuring

Incidence of Adverse Events and Serious Adverse Events

Timeframe: Up to 48 weeks

Trial details

NCT IDNCT07478822

SponsorChongqing Claruvis Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Jieru Bai

+86 13883955310 bai.jieru@claruvis.com

View on ClinicalTrials.gov More Upper Limb Spasticity trials