The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain and Sciatic Pain "BETA"

NCT05544656 | Active Not Recruiting Phase 3

• 1 other identifier: LOWBACK-SE-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the trial is to identify biomarkers from the blood as well as electrophysiologic and morphometric features (chemical, electrophysiologic and ultrasound biomarkers) that reflect the intensity of pain and/or foretell the efficacy of pharmacological (non-surgical) treatment in patients with acute low back pain.

Conditions

Low Back Pain

Keywords

back pain; sciatic pain; biomarkers

Outcome Measures

Primary Outcomes (2)

• Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values.

  Changes in the values of blood biomarkers (nociceptin/orphanin FQ, Met-Enkephalin-Arg6-Phe7 (MEAP), pro-inflammatory cytokines (IL-1β, IL-6, IL-2, IL-8, IL-12, IL-33, CCL3, CXCL1, CCR5, és TNF-α), anti-inflammatory cytokines (IL-10 and IL-4), monocyte chemoattractant protein-1 (MCP-1), macrophage inflammatory proteins-1b (MIP-1b), platelet-derived growth factor (PDGF AA), vascular endothelial growth factor (VEGF), GM-CSF=granulocyte-macrophage colony-stimulating factor, CGRP (calcitonin gene related peptide), substance P, noradrenalin (norepinephrine), in electrophysiologic markers (quantitative electromyography with surface electrodes in the paravertebral muscles in prone and standing position) and ultrasound markers (bilateral measurements of cross sectional area and antero-posterior diameter of paravertebral muscles in prone and standing position)

  14 days

• Patient reported change in pain features

  Self evaluation of pain by the patient on a visual scale from zero (no pain at all) to 10 (the most severe pain the patient can imagine)

  daily for 14 days

Secondary Outcomes (8)

• Change in the level of biomarkers enlisted in Primary Outcome 1 in the subgroup of those with ceased or greatly reduced pain

  14 days

• Change in the intensity of pain by the end of the treatment period

  14 days

• Change in the level of biomarkers enlisted in Primary Outcome 1 by the end of the treatment period in the tolperisone group

  14 days

• Change in the level of paravertebral muscle contraction by the end of the treatment period

  14 days

• Predictive value of the initial levels of biomarkers enlisted in Primary Outcome 1

  14 days

Other Outcomes (2)

• Patient reported sleep quality

  Daily from 1-14 days

• Fingertip-to-floor distance

  14 days

Study Arms (2)

Tolperisone

EXPERIMENTAL

Tolperisone 3 times 150 mg daily, i.e. a daily dose of 450 mg. Treatment lasts for 14 days

Drug: Tolperisone Hydrochloride

Placebo

PLACEBO COMPARATOR

Matching placebo 3 times daily. Treatment lasts for 14 days

Drug: Placebo

Interventions

Tolperisone Hydrochloride DRUG

Tolperisone Hydrochloride tablets of 150 mg, administered three times a day

Also known as: EV product code: PRD4558977, miderizone tablet, ATC:M03BX04

Tolperisone

Placebo DRUG

matching placebo administered three times a day

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy pain-free volunteers (n=30) outside of the randomized study, will participate to establish normal values of blood biomarkers.

You may not qualify if:

• pain, inflammation,

Sponsors & Collaborators

• Semmelweis University: lead
• National Research Develpment and Innovation Fund, Hungary: collaborator
• MEDITOP Pharmaceutical LTD, Hungary: collaborator

Study Sites (1)

Department of Neurology, Semmelweis University

Budapest, H-1083, Hungary

Location

MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Tolperisone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Daniel Bereczki, MD, POhD,DSc

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization is done by non-transparent (opaque) sequentially numbered envelopes, prepared independently from the trial site. The number on the envelope corresponds to the number on the boxes of the trial medication (tolperisone or matching placebo). The envelopes can be opened only at the end of the trial, or in case of emergency. No interim analysis is planned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of neurology

Model Details: Single center, randomized double blind study. Randomization is done separately for those with and those without radicular signs.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: September 16, 2022
• Study Start: December 13, 2019
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Infinite afer trial completion
• Access Criteria: request should be discussed by email of the principal investigator

Locations

HU (1)