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Using a new botulinum toxin injection to treat upper limb spasticity in adults

A Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults (REHAB-1)

Phase2; Phase3 Interventional Chongqing Claruvis Pharmaceutical Co., Ltd. · NCT06783114

This study is testing a new injection for adults with upper limb spasticity to see if it works better than current treatments like BOTOX® and helps improve their movement.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment254 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorChongqing Claruvis Pharmaceutical Co., Ltd. Industry-sponsored
Locations24 sites (Hefei, Anhui and 23 other locations)
Trial IDNCT06783114 on ClinicalTrials.gov

What this trial studies

This phase II study evaluates the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) for injection in adults with upper limb spasticity. It is a randomized, double-blind, dose escalation, placebo- and active-controlled trial involving multiple centers. Participants will receive either the experimental treatment, BOTOX®, or a placebo to assess improvements in spasticity and related functional abilities. The study aims to determine the optimal dosage and effectiveness of YY001 compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unilateral hemiplegia due to stroke and exhibiting upper limb spasticity.

Not a fit: Patients with a history of allergy to botulinum toxins or those who have used any botulinum toxin within the last six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from upper limb spasticity.

How similar studies have performed: Previous studies on botulinum toxin treatments have shown success, indicating potential for this novel formulation.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 randomized 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).
4. If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
5. If the study limb receives physical therapy or occupational therapy, the frequency, type, and intensity must be stable for at least 3 weeks prior to randomized enrollment.

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 randomized 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 randomized enrollment.

Where this trial is running

Hefei, Anhui and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Upper Limb SpasticityYY001Recombinant Botulinum Toxin Type ABotulinum ToxinUpper limb spasticity
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.