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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04671082
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : February 25, 2021
Information provided by (Responsible Party):
Neurana Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Back Muscle Spasm Back Pain Back Strain Back Spasm Upper Muscle Spasm Acute Pain Drug: Tolperisone Hydrochloride Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arm Intervention/treatment
Experimental: Tolperisone 50 mg
Tolperisone 50 mg
Drug: Tolperisone Hydrochloride
Other Name: Tolperisone

Experimental: Tolpersione 100 mg
Tolperisone 100 mg
Drug: Tolperisone Hydrochloride
Other Name: Tolperisone

Experimental: Tolperisone 200 mg
Tolperisone 200 mg
Drug: Tolperisone Hydrochloride
Other Name: Tolperisone

Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Numerical rating scale (NRS) [ Time Frame: Day 1 to Day 14 ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04671082

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Contact: Priya Desai 984-289-5479
Contact: Sanam Ara Vaughan

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Sponsors and Collaborators
Neurana Pharmaceuticals, Inc.
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Study Director: Randall Kaye, MD Neurana Pharmaceuticals
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Responsible Party: Neurana Pharmaceuticals, Inc. Identifier: NCT04671082    
Other Study ID Numbers: CLN-301
RESUME-1 ( Other Identifier: Neurana Pharmaceuticals )
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Cramp
Acute Pain
Neurologic Manifestations
Neuromuscular Manifestations
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents