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Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm (RESUME-1)

Primary Purpose

Back Muscle Spasm, Back Pain, Back Strain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tolperisone Hydrochloride
Placebo
Sponsored by
Neurana Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Muscle Spasm

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ambulatory
  • Current acute back pain due to acute muscle spasm starting within 7 days prior to study entry (Day 1) and at least 8 weeks following resolution of the last episode of acute back pain.
  • Willingness to discontinue all previous or ongoing treatment of pain or muscle spasm on study entry at Day 1 through the end of treatment including medication, acupuncture, chiropractic adjustment, massage, transcutaneous electrical nerve stimulation [TENS], or physiotherapy.
  • Pain must be localized from the neck (C-3 or lower) to the inferior gluteal folds and spasm assessed during the Screening physical examination.
  • Body mass index range between 18 and 35 kg/m², inclusive.

Exclusion Criteria:

  • Presence of acute or chronic back pain for the previous 8 days or longer, where back pain is present on more days than not.
  • Presence of neurogenic pain in the back, neck, upper or lower extremities, including pain from (or suspected from) nerve root compression or injury (radicular pain or "pinched nerve") or neuropathic pain. Evidence of these types of exclusionary pain includes radiation of pain that radiates beyond the back, chronic pain, and pain associated with abnormal sensation or loss of sensation in the back or extremities.
  • Presence of pain anywhere other than the target back pain that is bothersome, interferes with activity, or for which pain relief is taken.
  • History of any neck, back, or pelvic surgery.
  • History within the previous 3 years of: spinal fracture or spinal infection; inflammatory arthritis; degenerative spine disease; or any other back or spine condition that may reasonably contribute to current back pain.
  • Subjects who test positive for alcohol by breathalyzer test or have a positive urine drug screen for drugs of abuse (e.g. amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, oxycodone, opiates), including cannabis even where legal, at Screening.

Sites / Locations

  • Clinical Research Institute of Arizona, LLC
  • Applied Research Center of Arkansas
  • Alliance Research Institute
  • Long Beach Clinical Trials Services, Inc
  • Northern California Research
  • Collaborative Neuroscience Research, LLC
  • Lynn Institute of Denver
  • Emerson Clinical Research Institute
  • Multi-Specialty Research Associates, Inc.
  • Savin Medical Group
  • LCC Medical Research Institute, LLC
  • Accel Research Sites
  • Combined Research Orlando
  • iResearch Atlanta
  • Georgia Clinical Research LLC
  • IMA Clinical Research, PC
  • Evanston Premier Healthcare Research LLC
  • Investigators Research Group
  • Professional Research Network of Kansas, LLC
  • Research Integrity, LLC
  • DelRicht Research
  • DelRicht Research
  • Michigan Head Pain and Neurological Institute
  • Onyx Clinical Research
  • Quinn Healthcare/SKYCRNG
  • IMA Clinical Research
  • Pioneer Clinical Research, LLC
  • Skyline Medical Center, PC
  • Jubilee Clinical Research, Inc.
  • Albuquerque Clinical Trials, Inc.
  • Integrative Clinical Trials, LLC
  • Drug Trials America
  • Manhattan Behavioral Medicine PLLC
  • Advanced Research Solutions, LLC
  • Upstate ClinicalResearch Associates LLC
  • Carolina Research Center, Inc.
  • Progressive Medicine of the Triad, LLC
  • Hometown Urgent Care and Research
  • Hometown Urgent Care and Research
  • Hometown Urgent Care and Research
  • Onyx Clinical Research
  • Today Clinical Research
  • DelRicht Research
  • Frontier Clinical Research, LLC
  • PCPMG Clinical Research Unit, LLC
  • New Phase Research & Development, LLC
  • Central Texas Clinical Research
  • Premier Family Physicians
  • ClinRx Research Joseph INC
  • Centex Studies, Inc.
  • Centex Studies, Inc.
  • R & H Clinical Research
  • Village Health Partners
  • Sun Research Institute
  • Spectrum Medical, Inc.
  • Health Research of Hampton Roads, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Tolperisone 50 mg

Tolpersione 100 mg

Tolperisone 200 mg

Placebo

Arm Description

Tolperisone 50 mg

Tolperisone 100 mg

Tolperisone 200 mg

Placebo

Outcomes

Primary Outcome Measures

Numerical rating scale (NRS)
Numerical rating scale (NRS), a 0-10 scale, from no pain to worst possible pain - Subject-rated pain "right now" due to acute back spasm.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2020
Last Updated
March 21, 2022
Sponsor
Neurana Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04671082
Brief Title
Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
Acronym
RESUME-1
Official Title
A Phase 3, 14-Day, Double-blind, Randomized, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
March 21, 2022 (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, multicenter study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered in subjects with pain due to acute back muscle spasm.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1004 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tolperisone 50 mg
Arm Type
Experimental
Arm Description
Tolperisone 50 mg
Arm Title
Tolpersione 100 mg
Arm Type
Experimental
Arm Description
Tolperisone 100 mg
Arm Title
Tolperisone 200 mg
Arm Type
Experimental
Arm Description
Tolperisone 200 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Tolperisone Hydrochloride
Other Intervention Name(s)
Tolperisone
Intervention Description
TID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TID
Primary Outcome Measure Information:
Title
Numerical rating scale (NRS)
Description
Numerical rating scale (NRS), a 0-10 scale, from no pain to worst possible pain - Subject-rated pain "right now" due to acute back spasm.
Time Frame
Day 1 to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ambulatory Current acute back pain due to acute muscle spasm starting within 7 days prior to study entry (Day 1) and at least 8 weeks following resolution of the last episode of acute back pain. Willingness to discontinue all previous or ongoing treatment of pain or muscle spasm on study entry at Day 1 through the end of treatment including medication, acupuncture, chiropractic adjustment, massage, transcutaneous electrical nerve stimulation [TENS], or physiotherapy. Pain must be localized from the neck (C-3 or lower) to the inferior gluteal folds and spasm assessed during the Screening physical examination. Body mass index range between 18 and 35 kg/m², inclusive. Exclusion Criteria: Presence of acute or chronic back pain for the previous 8 days or longer, where back pain is present on more days than not. Presence of neurogenic pain in the back, neck, upper or lower extremities, including pain from (or suspected from) nerve root compression or injury (radicular pain or "pinched nerve") or neuropathic pain. Evidence of these types of exclusionary pain includes radiation of pain that radiates beyond the back, chronic pain, and pain associated with abnormal sensation or loss of sensation in the back or extremities. Presence of pain anywhere other than the target back pain that is bothersome, interferes with activity, or for which pain relief is taken. History of any neck, back, or pelvic surgery. History within the previous 3 years of: spinal fracture or spinal infection; inflammatory arthritis; degenerative spine disease; or any other back or spine condition that may reasonably contribute to current back pain. Subjects who test positive for alcohol by breathalyzer test or have a positive urine drug screen for drugs of abuse (e.g. amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, oxycodone, opiates), including cannabis even where legal, at Screening.
Facility Information:
Facility Name
Clinical Research Institute of Arizona, LLC
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
Country
United States
Facility Name
Applied Research Center of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Alliance Research Institute
City
Canoga Park
State/Province
California
ZIP/Postal Code
91304
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
95821
Country
United States
Facility Name
Collaborative Neuroscience Research, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Lynn Institute of Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Emerson Clinical Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Multi-Specialty Research Associates, Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Savin Medical Group
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
LCC Medical Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Accel Research Sites
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Combined Research Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Georgia Clinical Research LLC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30044
Country
United States
Facility Name
IMA Clinical Research, PC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Evanston Premier Healthcare Research LLC
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Investigators Research Group
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Professional Research Network of Kansas, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Research Integrity, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
DelRicht Research
City
Prairieville
State/Province
Louisiana
ZIP/Postal Code
70769
Country
United States
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Onyx Clinical Research
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Quinn Healthcare/SKYCRNG
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
IMA Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Pioneer Clinical Research, LLC
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
Skyline Medical Center, PC
City
Elkhorn
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Jubilee Clinical Research, Inc.
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
Integrative Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Manhattan Behavioral Medicine PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Advanced Research Solutions, LLC
City
Staten Island
State/Province
New York
ZIP/Postal Code
10302
Country
United States
Facility Name
Upstate ClinicalResearch Associates LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Carolina Research Center, Inc.
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Progressive Medicine of the Triad, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Onyx Clinical Research
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44505
Country
United States
Facility Name
Today Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73129
Country
United States
Facility Name
DelRicht Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
PCPMG Clinical Research Unit, LLC
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
New Phase Research & Development, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Premier Family Physicians
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Facility Name
ClinRx Research Joseph INC
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
R & H Clinical Research
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Village Health Partners
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Spectrum Medical, Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
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
Citations:
PubMed Identifier
34192885
Citation
Vaughan SA, Torres K, Kaye R. RESUME-1: a Phase III study of tolperisone in the treatment of painful, acute muscle spasms of the back. Pain Manag. 2022 Jan;12(1):25-33. doi: 10.2217/pmt-2021-0041. Epub 2021 Jul 1.
Results Reference
derived

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Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm

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