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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting
• The Second People's Hospital of Hefei
  Hefei, Anhui, China Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Chongqing Traditional Chinese Medicine Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Xinhua Wan — Peking Union Medical College Hospital
• Study coordinator: Jieru Bai
• Email: bai.jieru@claruvis.com
• Phone: +86 13883955310

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Recombinant botulinum toxin (YY001) injections for adult upper limb spasticity.

  This trial will test repeated injections of recombinant botulinum toxin type A (YY001) to reduce muscle stiffness and improve function in adults with post-stroke upper limb spasticity.

  Recruiting at 16 sites Phase 3 Chongqing Claruvis Pharmaceutical Co., Ltd. · Beijing and 15 other locations · NCT07478822

• Eveotox for Adult Upper Limb Spasticity: A Phase 3 Comparison to Placebo

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.