A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity

Physician's Global Assessment (PGA) Score

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.

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

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).

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

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.

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

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).

Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment