Table 1.

Summary of measures for assessment of spasticity and associated symptoms in the composite primary efficacy endpoint.

Functional domain and measure used	Assessment scale
Muscle spasticity MAS [22]	0	No increase in muscle tone	MAS ≥2 indicates moderate to severe spasticity
	1	Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
	1+	Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion
	2	More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved
	3	Considerable increase in muscle tone, passive movement difficult
	4	Affected part(s) rigid in flexion or extension
Pain NPRS [21]	0 = no pain		NPRS ≥4 indicates appearance or reappearance of active symptoms of spasticity
	1–3 = mild pain
	4–6 = moderate pain
	7–10 = severe pain (disabling and impacts upon movement)
Likert scale for evaluation of passive function in the relevant upper limb	“In general, how much does spasticity have an impact on the following activities of daily living and/or your rehabilitation program: hygiene (i.e. hand, nails, armpit, elbows), dressing the limb, positioning the limb, splint application or removal?”
	1.No impact 2.Mild impact 3.Moderate impact 4.Severe impact		A score ≥1 indicates appearance or reappearance of passive symptoms of spasticity
Likert scale for evaluation of active function in the relevant upper limb	“In general, how much does spasticity have an impact on the following activities of daily living and/or your rehabilitation program: reaching, grasping, releasing, gripping, holding, bimanual function, manipulating objects, dexterity, fine motor skills, lifting and carrying?”
	1.No impact 2.Mild impact 3.Moderate impact 4.Severe impact		A score ≥1 indicates appearance or reappearance of active symptoms of spasticity
Likert scale for evaluation of involuntary movements (including associated reactions in the relevant upper limb)	1.No involuntary movements 2.Presence of involuntary movements which have a mild impact on posture and ambulation 3.Presence of involuntary movements which have a moderate impact on posture and ambulation 4.Presence of involuntary movements which have a severe impact on posture and ambulation		A score ≥1 indicates appearance or reappearance of involuntary movements
Likert scale for global assessment of changes	“How does your patient feel compared to his/her condition at the first visit?”
	•Much better •Better •No change •Worse •Much worse

MAS, modified Ashworth scale; NPRS, Numeric Pain Rating Scale.