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Recruiting NCT06783114

A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults

Phase II / Phase III Interventional Upper Limb Spasticity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Recombinant Botulinum Toxin Type A for injection (YY001), BOTOX®, Placebo.
Who it may be relevant to
Registry conditions: Upper Limb Spasticity. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

This is a randomized, double-blind, multi-center phase II/III 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

Interventions

  • Biological Recombinant Botulinum Toxin Type A for injection (YY001)
    Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200-400 U.
  • Biological BOTOX®
    Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U.
  • Biological Placebo
    Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.

Primary outcome measures

  • Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4 [Time frame: Week 4 after treatment]
Secondary outcome measures (6)
  • Physician's Global Assessment (PGA) Score at Week 1, Week 4, Week 8 and Week 12 [Time frame: Week 1, Week 4, Week 8 and Week 12 after treatment]
  • Change From Baseline in MAS Score of Primary Target Clinical Pattern at Week 1, Week 8, Week 12 [Time frame: Week 1, Week 8 and Week 12 after treatment]
  • Response Rates on MAS Calculated for the Primary Target Clinical Pattern at Week 1, Week 4, Week 8 and Week 12 [Time frame: Week 1, Week 4, Week 8 and Week 12 after treatment]
  • Changes From Baseline in Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain at Week 1, Week 4, Week 8 and Week 12 [Time frame: Week 1, Week 4, Week 8 and Week 12 after treatment]
  • Incidence of Adverse Events and Serious Adverse Events [Time frame: Within 12 weeks of treatment]
  • Incidence of Anti-drug Antibodies and Neutralizing Antibodies [Time frame: Within 12 weeks of treatment]

Eligibility criteria

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 randomized 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).
  • If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
  • 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

  • History of allergy to any component of the experimental drugs.
  • 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.
  • 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.
  • Participation in other drug/device clinical trials within 1 month prior to randomized enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 24 centers
  • Anhui Provincial Hospital — Hefei
  • The Second People's Hospital of Hefei — Hefei
  • Peking Union Medical College Hospital — Beijing
  • Chongqing Traditional Chinese Medicine Hospital — Chongqing
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • Guangdong Provincial People's Hospital — Guangzhou
  • Sun Yat-sen Memorial Hospital — Guangzhou
  • Shenzhen Second People's Hospital — Shenzhen
  • … and 16 more centers

Identifiers

NCT: NCT06783114 · YY001-002-CN01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗