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

NCT05544656 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-04-17

No results posted yet for this study

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

Interventions

DRUG

Tolperisone Hydrochloride

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

DRUG

Placebo

matching placebo administered three times a day

Sponsors & Collaborators

  • National Research Develpment and Innovation Fund, Hungary

    collaborator UNKNOWN

  • MEDITOP Pharmaceutical LTD, Hungary

    collaborator UNKNOWN

  • Semmelweis University

    lead OTHER

Principal Investigators

  • Daniel Bereczki, MD, POhD,DSc · Semmelweis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-13
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05544656 on ClinicalTrials.gov