Trial Outcomes & Findings for Tolperisone in Acute Muscle Spasm of the Back (NCT NCT03802565)
NCT ID: NCT03802565
Last Updated: 2022-02-01
Results Overview
Mean effect size between Tolperisone and Placebo of subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain) on Day 14 "right now."
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
415 participants
Primary outcome timeframe
Day 1 to Day 14
Results posted on
2022-02-01
Participant Flow
Participant milestones
| Measure |
Tolperisone 50 mg
TID (150 mg/day)
Tolperisone: TID
|
Tolperisone 100 mg
TID (300 mg/day)
Tolperisone: TID
|
Tolperisone 150 mg
TID (450 mg/day)
Tolperisone: TID
|
Tolperisone 200 mg
TID (600 mg/day)
Tolperisone: TID
|
Placebo
TID
Placebo: Placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
87
|
83
|
85
|
78
|
|
Overall Study
COMPLETED
|
77
|
83
|
74
|
77
|
72
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
9
|
8
|
6
|
Reasons for withdrawal
| Measure |
Tolperisone 50 mg
TID (150 mg/day)
Tolperisone: TID
|
Tolperisone 100 mg
TID (300 mg/day)
Tolperisone: TID
|
Tolperisone 150 mg
TID (450 mg/day)
Tolperisone: TID
|
Tolperisone 200 mg
TID (600 mg/day)
Tolperisone: TID
|
Placebo
TID
Placebo: Placebo
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
4
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Subjects Related to Each Other
|
1
|
0
|
0
|
2
|
1
|
|
Overall Study
Elevated Enzymes
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Tolperisone in Acute Muscle Spasm of the Back
Baseline characteristics by cohort
| Measure |
Tolperisone 50 mg
n=82 Participants
TID (150 mg/day)
Tolperisone: TID
|
Tolperisone 100 mg
n=87 Participants
TID (300 mg/day)
Tolperisone: TID
|
Tolperisone 150 mg
n=83 Participants
TID (450 mg/day)
Tolperisone: TID
|
Tolperisone 200 mg
n=85 Participants
TID (600 mg/day)
Tolperisone: TID
|
Placebo
n=78 Participants
TID
Placebo: Placebo
|
Total
n=415 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
|
43.5 years
n=5 Participants
|
44.4 years
n=7 Participants
|
44.3 years
n=5 Participants
|
42.0 years
n=4 Participants
|
41.6 years
n=21 Participants
|
43.6 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
233 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
182 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
89 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
326 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
154 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
236 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Body Mass Index
|
28.23 kilogram/meter^2
n=5 Participants
|
28.48 kilogram/meter^2
n=7 Participants
|
28.34 kilogram/meter^2
n=5 Participants
|
28.45 kilogram/meter^2
n=4 Participants
|
28.53 kilogram/meter^2
n=21 Participants
|
28.38 kilogram/meter^2
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Mean effect size between Tolperisone and Placebo of subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain) on Day 14 "right now."
Outcome measures
| Measure |
Tolperisone 50 mg
n=82 Participants
TID (150 mg/day)
Tolperisone: TID
|
Tolperisone 100 mg
n=87 Participants
TID (300 mg/day)
Tolperisone: TID
|
Tolperisone 150 mg
n=83 Participants
TID (450 mg/day)
Tolperisone: TID
|
Tolperisone 200 mg
n=85 Participants
TID (600 mg/day)
Tolperisone: TID
|
Placebo
n=78 Participants
TID
Placebo: Placebo
|
|---|---|---|---|---|---|
|
Mean Effect Size in Subjected-Rated Pain
|
-4.2 score on a scale
Interval -9.0 to 1.0
|
-4.0 score on a scale
Interval -10.0 to 2.0
|
-3.7 score on a scale
Interval -8.0 to 1.0
|
-4.4 score on a scale
Interval -10.0 to 1.0
|
-3.5 score on a scale
Interval -8.0 to 1.0
|
Adverse Events
Tolperisone 50 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Tolperisone 100 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Tolperisone 150 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Tolperisone 200 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tolperisone 50 mg
n=82 participants at risk
TID (150 mg/day)
Tolperisone: TID
|
Tolperisone 100 mg
n=87 participants at risk
TID (300 mg/day)
Tolperisone: TID
|
Tolperisone 150 mg
n=83 participants at risk
TID (450 mg/day)
Tolperisone: TID
|
Tolperisone 200 mg
n=85 participants at risk
TID (600 mg/day)
Tolperisone: TID
|
Placebo
n=78 participants at risk
TID
Placebo: Placebo
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
3.7%
3/82 • First Dose, Day 1 to Follow-up, Day 28
|
5.7%
5/87 • First Dose, Day 1 to Follow-up, Day 28
|
9.6%
8/83 • First Dose, Day 1 to Follow-up, Day 28
|
9.4%
8/85 • First Dose, Day 1 to Follow-up, Day 28
|
3.8%
3/78 • First Dose, Day 1 to Follow-up, Day 28
|
|
Nervous system disorders
Dizziness
|
1.2%
1/82 • First Dose, Day 1 to Follow-up, Day 28
|
2.3%
2/87 • First Dose, Day 1 to Follow-up, Day 28
|
0.00%
0/83 • First Dose, Day 1 to Follow-up, Day 28
|
2.4%
2/85 • First Dose, Day 1 to Follow-up, Day 28
|
0.00%
0/78 • First Dose, Day 1 to Follow-up, Day 28
|
|
Nervous system disorders
Somnolence
|
0.00%
0/82 • First Dose, Day 1 to Follow-up, Day 28
|
3.4%
3/87 • First Dose, Day 1 to Follow-up, Day 28
|
0.00%
0/83 • First Dose, Day 1 to Follow-up, Day 28
|
1.2%
1/85 • First Dose, Day 1 to Follow-up, Day 28
|
2.6%
2/78 • First Dose, Day 1 to Follow-up, Day 28
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
2/82 • First Dose, Day 1 to Follow-up, Day 28
|
2.3%
2/87 • First Dose, Day 1 to Follow-up, Day 28
|
3.6%
3/83 • First Dose, Day 1 to Follow-up, Day 28
|
1.2%
1/85 • First Dose, Day 1 to Follow-up, Day 28
|
0.00%
0/78 • First Dose, Day 1 to Follow-up, Day 28
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/82 • First Dose, Day 1 to Follow-up, Day 28
|
1.1%
1/87 • First Dose, Day 1 to Follow-up, Day 28
|
1.2%
1/83 • First Dose, Day 1 to Follow-up, Day 28
|
2.4%
2/85 • First Dose, Day 1 to Follow-up, Day 28
|
0.00%
0/78 • First Dose, Day 1 to Follow-up, Day 28
|
Additional Information
Randall Kaye, MD - Chief Medical Officer
Neurana Pharmaceuticals, Inc.
Phone: 858-732-0708
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place