Recruiting NCT07478822
A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult 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).
- 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
An Open-label, Multicenter Clinical Study on The Long-term Safety and Efficacy of Multiple Treatments With Recombinant Botulinum Toxin Type A (YY001) for Injection in Adult Upper Limb Spasticity (REHAB-2)
Overview
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
Interventions
- Biological Recombinant botulinum toxin type A for injection (YY001)
Prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose for single treatment is 200 to 400 U.
Primary outcome measures
- Incidence of Adverse Events and Serious Adverse Events [Time frame: Up to 48 weeks]
Secondary outcome measures (5)
- Physician's Global Assessment (PGA) Score [Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment]
- Change From Baseline in MAS Score of Primary Target Clinical Pattern [Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment]
- Response Rates on MAS Calculated for the Primary Target Clinical Pattern [Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment]
- The Proportion with Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain Score Reduction of ≥1 Point [Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment]
- Incidence of Anti-drug Antibodies and Neutralizing Antibodies [Time frame: Up to 48 weeks]
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 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.
- Participation in other drug/device clinical trials within 1 month prior to 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
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 16 centers
- Peking Union Medical College Hospital — Beijing
- West China Hospital，Sichuan University — Chengdu
- Guangdong Provincial People's Hospital — Guangdong
- Sun Yat-sen Memorial Hospital — Guangzhou
- The Second People's Hospital of Hefei — Hefei
- Huai'an First Hospital Affiliated to Nanjing Medical University — Huai'an
- The First Affiliated Hospital of Henan University — Kaifeng
- The Second Affiliated Hospital of Kunming Medical University — Kunming
- … and 8 more centers
Identifiers
NCT: NCT07478822 · YY001-002-CN02