Phase 2: STAR Study

Subject-rated Pain

(NRS)

Placebo

200 mg TID

150 mg TID

100 mg TID

50 mg TID 

RANDOMIZATION

DAY

4

Follow-up

Daily ePRO Pain Assessments through Day 14

Screening & Enrollment

1

14

21

415 patients

18 - 65 years

Current acute back pain and/or stiffness due to acute and painful muscle spasm

Numerical Rating Scale

(NRS) pain of 4 or more at baseline 

Significant Change in NRS Seen with Tolperisone 200mg Dose from Baseline

Mean Change in NRS from Baseline

NRS_200mgChart.png

Day

1

2

3

4

5

6

7

8

9

10

11

12

13

14

0

-0.5

-1

-1.5

-2

-2.5

-3

-3.5

-4

-4.5

-5

Placebo

100 mg

200 mg

Twice as Many Patients Were Early Responders Compared to Placebo at Day 4

Placebo

100mg

200mg

Early Responders defined as having a NRS score of 0, 1 or 2

# of Patients

25%

20%

15%

10%

5%

0%

Tolperisone Comparable to Placebo Across All Doses on Measures of Sleepiness

# of Patients

10

8

6

4

2

0

10 = Very sleepy, difficulty remaining awake 

0 = Alert, wide awake

Placebo

50mg

100mg

150mg

200mg

As assessed by the VAS for sleepiness on a scale of 0 to 10, where 0=alert, wide awake to 10=very sleepy, difficulty remaining awake