Upper Limb Spasticity
Conditions
Keywords
YY001, Recombinant Botulinum Toxin Type A, Botulinum Toxin, Upper limb spasticity
Brief summary
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
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200-400 U.
BIOLOGICALBOTOX®
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U.
BIOLOGICALPlacebo
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.
Sponsors
Chongqing Claruvis Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
Placebo- and active-controlled
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4 | Week 4 after 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Global Assessment (PGA) Score at Week 1, Week 4, Week 8 and Week 12 | Week 1, Week 4, Week 8 and Week 12 after 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 at Week 1, Week 8, Week 12 | 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 | Week 1, Week 4, Week 8 and Week 12 after 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. |
| Changes From Baseline in Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain at Week 1, Week 4, Week 8 and Week 12 | Week 1, Week 4, Week 8 and Week 12 after 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 Adverse Events and Serious Adverse Events | Within 12 weeks of treatment | — |
| Incidence of Anti-drug Antibodies and Neutralizing Antibodies | Within 12 weeks of treatment | — |
Countries
China
Contacts
CONTACTJieru Bai
CONTACTXiaoyun Sun, Ph.D
PRINCIPAL_INVESTIGATORXinhua Wan
Peking Union Medical College Hospital
Outcome results
None listed