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

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 open-label, multicenter Phase 3 trial in China administers multiple treatment cycles of recombinant botulinum toxin type A (YY001) to adults with unilateral post-stroke upper limb spasticity to gather long-term safety and efficacy data. Eligible participants are 18–75 years old, at least 3 months from stroke onset, and have a Disability Assessment Scale score of at least 2 on the principal target domain. Key exclusions include fixed contractures, allergy to study drug components, prior botulinum toxin use within 6 months, or need for medications that interfere with neuromuscular function. Participants receive injections at participating hospitals with scheduled follow-up visits to monitor adverse events and changes in muscle tone and functional outcomes.

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 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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting
• West China Hospital，Sichuan University
  Chengdu, China Recruiting
• Guangdong Provincial People's Hospital
  Guangdong, China Recruiting
• Sun Yat-sen Memorial Hospital
  Guangzhou, China Recruiting
• The Second People's Hospital of Hefei
  Hefei, China Recruiting
• Huai'an First Hospital Affiliated to Nanjing Medical University
  Huai'an, China Recruiting

Study contacts

• Study coordinator: Jieru Bai
• Email: bai.jieru@claruvis.com
• Phone: +86 13883955310

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

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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.