Tolperisone in Acute Muscle Spasm of the Back (STAR)

• ClinicalTrials.gov Identifier: NCT03802565
• Recruitment Status: Completed
• First Posted: January 14, 2019
• Results First Posted: November 10, 2020
• Last Update Posted: February 1, 2022
• Sponsor: Neurana Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Neurana Pharmaceuticals, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Conditions: Back Pain; Acute Pain; Back Spasm Upper Back; Back Strain; Muscle Cramp; Muscle Spasm; Low Back Pain
• Interventions: Drug: Tolperisone; Drug: Placebo
• Enrollment: 415

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Tolperisone 50 mg	Tolperisone 100 mg	Tolperisone 150 mg	Tolperisone 200 mg	Placebo
Arm/Group Description	TID (150 mg/day) Tolperisone: TID	TID (300 mg/day) Tolperisone: TID	TID (450 mg/day) Tolperisone: TID	TID (600 mg/day) Tolperisone: TID	TID Placebo: Placebo
Period Title: Overall Study
Started	82	87	83	85	78
Completed	77	83	74	77	72
Not Completed	5	4	9	8	6
Reason Not Completed
Adverse Event	0	1	2	1	1
Withdrawal by Subject	2	2	2	0	1
Protocol Violation	2	1	4	5	1
Lost to Follow-up	0	0	1	0	0
Subjects Related to Each Other	1	0	0	2	1
Elevated Enzymes	0	0	0	0	2

Baseline Characteristics

Arm/Group Title		Tolperisone 50 mg	Tolperisone 100 mg	Tolperisone 150 mg	Tolperisone 200 mg	Placebo	Total
Arm/Group Description		TID (150 mg/day) Tolperisone: TID	TID (300 mg/day) Tolperisone: TID	TID (450 mg/day) Tolperisone: TID	TID (600 mg/day) Tolperisone: TID	TID Placebo: Placebo	Total of all reporting groups
Overall Number of Baseline Participants		82	87	83	85	78	415
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Mean (Full Range); Unit of measure: Years
	Number Analyzed	82 participants	87 participants	83 participants	85 participants	78 participants	415 participants
		43.5; (20 to 65)	44.4; (19 to 65)	44.3; (21 to 65)	42.0; (20 to 64)	41.6; (18 to 62)	43.6; (18 to 65)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	82 participants	87 participants	83 participants	85 participants	78 participants	415 participants
	Female	45 54.9%	57 65.5%	41 49.4%	41 48.2%	49 62.8%	233 56.1%
	Male	37 45.1%	30 34.5%	42 50.6%	44 51.8%	29 37.2%	182 43.9%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	82 participants	87 participants	83 participants	85 participants	78 participants	415 participants
	Hispanic or Latino	13 15.9%	18 20.7%	22 26.5%	20 23.5%	16 20.5%	89 21.4%
	Not Hispanic or Latino	69 84.1%	69 79.3%	61 73.5%	65 76.5%	62 79.5%	326 78.6%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	82 participants	87 participants	83 participants	85 participants	78 participants	415 participants
	American Indian or Alaska Native	1 1.2%	0 0.0%	1 1.2%	0 0.0%	1 1.3%	3 0.7%
	Asian	1 1.2%	4 4.6%	2 2.4%	4 4.7%	3 3.8%	14 3.4%
	Native Hawaiian or Other Pacific Islander	1 1.2%	1 1.1%	1 1.2%	0 0.0%	0 0.0%	3 0.7%
	Black or African American	29 35.4%	32 36.8%	29 34.9%	35 41.2%	29 37.2%	154 37.1%
	White	50 61.0%	50 57.5%	49 59.0%	45 52.9%	42 53.8%	236 56.9%
	More than one race	0 0.0%	0 0.0%	1 1.2%	0 0.0%	3 3.8%	4 1.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	1 1.2%	0 0.0%	1 0.2%
Body Mass Index; Mean (Full Range); Unit of measure: Kilogram/meter^2
	Number Analyzed	82 participants	87 participants	83 participants	85 participants	78 participants	415 participants
		28.23; (19.4 to 35.0)	28.48; (20.9 to 35.0)	28.34; (19.8 to 35.0)	28.45; (20.0 to 35.0)	28.53; (19.5 to 35.0)	28.38; (19.4 to 35.0)

Outcome Measures

1. Primary Outcome

Title	Mean Effect Size in Subjected-Rated Pain
Description	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."
Time Frame	Day 1 to Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tolperisone 50 mg	Tolperisone 100 mg	Tolperisone 150 mg	Tolperisone 200 mg	Placebo
Arm/Group Description:	TID (150 mg/day) Tolperisone: TID	TID (300 mg/day) Tolperisone: TID	TID (450 mg/day) Tolperisone: TID	TID (600 mg/day) Tolperisone: TID	TID Placebo: Placebo
Overall Number of Participants Analyzed	82	87	83	85	78
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-4.2; (-9 to 1)	-4.0; (-10 to 2)	-3.7; (-8 to 1)	-4.4; (-10 to 1)	-3.5; (-8 to 1)

Adverse Events

Time Frame	First Dose, Day 1 to Follow-up, Day 28
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Tolperisone 50 mg	Tolperisone 100 mg	Tolperisone 150 mg	Tolperisone 200 mg	Placebo
Arm/Group Description	TID (150 mg/day) Tolperisone: TID	TID (300 mg/day) Tolperisone: TID	TID (450 mg/day) Tolperisone: TID	TID (600 mg/day) Tolperisone: TID	TID Placebo: Placebo
All-Cause Mortality
	Tolperisone 50 mg	Tolperisone 100 mg	Tolperisone 150 mg	Tolperisone 200 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/82 (0.00%)	0/87 (0.00%)	0/83 (0.00%)	0/85 (0.00%)	0/78 (0.00%)
Serious Adverse Events
	Tolperisone 50 mg	Tolperisone 100 mg	Tolperisone 150 mg	Tolperisone 200 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/82 (0.00%)	0/87 (0.00%)	0/83 (0.00%)	0/85 (0.00%)	0/78 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Tolperisone 50 mg	Tolperisone 100 mg	Tolperisone 150 mg	Tolperisone 200 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	7/82 (8.54%)	13/87 (14.94%)	12/83 (14.46%)	14/85 (16.47%)	5/78 (6.41%)
Gastrointestinal disorders
Diarrhoea †	2/82 (2.44%)	2/87 (2.30%)	3/83 (3.61%)	1/85 (1.18%)	0/78 (0.00%)
Nausea †	1/82 (1.22%)	1/87 (1.15%)	1/83 (1.20%)	2/85 (2.35%)	0/78 (0.00%)
Nervous system disorders
Headache †	3/82 (3.66%)	5/87 (5.75%)	8/83 (9.64%)	8/85 (9.41%)	3/78 (3.85%)
Dizziness †	1/82 (1.22%)	2/87 (2.30%)	0/83 (0.00%)	2/85 (2.35%)	0/78 (0.00%)
Somnolence †	0/82 (0.00%)	3/87 (3.45%)	0/83 (0.00%)	1/85 (1.18%)	2/78 (2.56%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Randall Kaye, MD - Chief Medical Officer
• Organization: Neurana Pharmaceuticals, Inc.
• Phone: 858-732-0708
• EMail: rkaye@neuranapharma.com

• Responsible Party: Neurana Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03802565
• Other Study ID Numbers: 201
• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Results First Submitted: October 19, 2020
• Results First Posted: November 10, 2020
• Last Update Posted: February 1, 2022