Upper Limb Spasticity
Conditions
Keywords
Botulinum Toxin, Recombinant Botulinum Toxin Type A, YY001, Upper limb spasticity
Brief summary
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
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.
Sponsors
Chongqing Claruvis Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events and Serious Adverse Events | Up to 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Global Assessment (PGA) Score | Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment | The Physician's Global Assessment is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point scale that ranges from -3 = very much worse to +3 = very much improved. |
| Change From Baseline in MAS Score of Primary Target Clinical Pattern | Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed elbow or flexed wrist or clenched fist. The Modified Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 6-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Response Rates on MAS Calculated for the Primary Target Clinical Pattern | Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed elbow or flexed wrist or clenched fist. Subjects with a MAS reduction of one point were defined as responder. |
| The Proportion with Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain Score Reduction of ≥1 Point | Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment | The DAS consists of the four domains hygiene, dressing, limb position and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Incidence of Anti-drug Antibodies and Neutralizing Antibodies | Up to 48 weeks | — |
Countries
China
Contacts
CONTACTJieru Bai
CONTACTXiaoyun Sun
Outcome results
None listed