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Tolperisone in Acute Muscle Spasm of the Back (STAR)

Primary Purpose

Back Pain, Acute Pain, Back Spasm Upper Back

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tolperisone
Placebo
Sponsored by
Neurana Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ambulatory
  • Current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain.
  • Pain of 4 or more on the subject "right now" rating of pain intensity Numeric Rating Scale (NRS) scale of 0-10.
  • Willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry.
  • Pain localized below the neck and above the inferior gluteal folds.
  • Body mass index ranging between 18 and 35 kg/m².

Exclusion Criteria:

  • Unwillingness to stop taking pain or antispasmodic medication other than the study medication (specifically opioid use [e.g., Vicodin], barbiturates, and cannabis).
  • Chronic pain for the previous 3 months or longer, on more days than not.
  • Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy).
  • Concomitant severe pain in a region other than the back.
  • Spinal surgery within 1 year of study entry.
  • Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year.
  • Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation [TENS], physiotherapy).
  • Subjects who test positive for alcohol by breathalyzer test.
  • Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP) isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).

Sites / Locations

  • Tennessee Valley Pain Consultants
  • Fiel Family and Sports Medicine
  • Center of Applied Research
  • Research Center of Fresno
  • Long Beach Clinical Trials Services, Inc.
  • Northern California Research
  • Pacific Research Network, LLC
  • San Diego Sports Medicine
  • CITrials
  • Riverside Clinical Research
  • Empirical Research Group
  • Savin Medical Group
  • LLC Medical Research
  • Avail Clinical Research
  • Private Practice
  • NeuroTrials Research, Inc.
  • Georgia Institute for Clinical Research
  • Georgia Clinical Research
  • MediSphere Medical Research Center
  • Otrimed Clinical Research
  • Centex Studies, Inc.
  • Center for Rheumatology and Bone
  • Michigan Head Pain and Neurological
  • Sundance Clinical Research
  • Jubilee Clinical Research
  • Albuquerque Clinical Trials, Inc.
  • Upstate Clinical Research Associates
  • Clinical Trials of America
  • Sterling Research Group- Springdale
  • Cleveland Clinic
  • Center for Providence Health Partners
  • IPS Research
  • Williamette Valley Clinical Studies
  • Frontier Clinical Research, Inc.
  • Omega Medical Research
  • Health Concepts
  • Inquest Clinical Research
  • DiscoveResearch, Inc.
  • HD Research Corp
  • Centex Studies, Inc.
  • ClinRX Research Joseph, Inc.
  • Highland Clinical Research
  • Health Research of Hampton Roads, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Tolperisone 50 mg

Tolperisone 100 mg

Tolperisone 150 mg

Tolperisone 200 mg

Placebo

Arm Description

TID (150 mg/day)

TID (300 mg/day)

TID (450 mg/day)

TID (600 mg/day)

TID

Outcomes

Primary Outcome Measures

Mean Effect Size in Subjected-Rated Pain
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."

Secondary Outcome Measures

Full Information

First Posted
January 10, 2019
Last Updated
January 28, 2022
Sponsor
Neurana Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03802565
Brief Title
Tolperisone in Acute Muscle Spasm of the Back
Acronym
STAR
Official Title
Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurana Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three times a day (TID) in approximately 400 male and female subjects experiencing back pain due to or associated with muscle spasm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Acute Pain, Back Spasm Upper Back, Back Strain, Muscle Cramp, Muscle Spasm, Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tolperisone 50 mg
Arm Type
Experimental
Arm Description
TID (150 mg/day)
Arm Title
Tolperisone 100 mg
Arm Type
Experimental
Arm Description
TID (300 mg/day)
Arm Title
Tolperisone 150 mg
Arm Type
Experimental
Arm Description
TID (450 mg/day)
Arm Title
Tolperisone 200 mg
Arm Type
Experimental
Arm Description
TID (600 mg/day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
TID
Intervention Type
Drug
Intervention Name(s)
Tolperisone
Intervention Description
TID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ambulatory Current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain. Pain of 4 or more on the subject "right now" rating of pain intensity Numeric Rating Scale (NRS) scale of 0-10. Willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry. Pain localized below the neck and above the inferior gluteal folds. Body mass index ranging between 18 and 35 kg/m². Exclusion Criteria: Unwillingness to stop taking pain or antispasmodic medication other than the study medication (specifically opioid use [e.g., Vicodin], barbiturates, and cannabis). Chronic pain for the previous 3 months or longer, on more days than not. Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy). Concomitant severe pain in a region other than the back. Spinal surgery within 1 year of study entry. Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year. Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation [TENS], physiotherapy). Subjects who test positive for alcohol by breathalyzer test. Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP) isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).
Facility Information:
Facility Name
Tennessee Valley Pain Consultants
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Fiel Family and Sports Medicine
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Center of Applied Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Research Center of Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93702
Country
United States
Facility Name
Long Beach Clinical Trials Services, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Pacific Research Network, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Diego Sports Medicine
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
CITrials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Empirical Research Group
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32653
Country
United States
Facility Name
Savin Medical Group
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
LLC Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Avail Clinical Research
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Private Practice
City
Plantation
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
NeuroTrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Georgia Institute for Clinical Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Georgia Clinical Research
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
MediSphere Medical Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Otrimed Clinical Research
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Centex Studies, Inc.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Center for Rheumatology and Bone
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Michigan Head Pain and Neurological
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Sundance Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Jubilee Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Upstate Clinical Research Associates
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Clinical Trials of America
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sterling Research Group- Springdale
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Center for Providence Health Partners
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
IPS Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Williamette Valley Clinical Studies
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Frontier Clinical Research, Inc.
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
DiscoveResearch, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
HD Research Corp
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Centex Studies, Inc.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
ClinRX Research Joseph, Inc.
City
Plano
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Highland Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Health Research of Hampton Roads, Inc.
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tolperisone in Acute Muscle Spasm of the Back

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