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

NCT ID: NCT05544656

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-13
• Study Completion Date: 2024-06-30

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.

Detailed Description

The investigators include patients aged 18-80 years with acute (less than 1-month) low back pain with or without radicular signs, who do not have severe diseases (abscess, tumor, etc) in the background, already had CT or MRI scan during routine workup, and who have given written consent to participate in the study. Exclusion criteria are pregnancy, hypersensitivity to tolperisone in the history, severe liver or kidney disease, other severe diseases (abscess, tumor, etc) in the background of pain. The patients will be given 3 times daily 150 mg tolperisone or placebo in addition to standard therapy in a randomized double-blind design. Treatment will last for 14 days and a final follow-up is performed at 21 days. Clinical condition and biomarkers will be tested before treatment and at 14 days. Patients fill in a diary on a daily basis.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tolperisone

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

Group Type: EXPERIMENTAL

Tolperisone Hydrochloride

Intervention Type: DRUG

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

Placebo

Matching placebo 3 times daily. Treatment lasts for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching placebo administered three times a day

Interventions

Tolperisone Hydrochloride

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

Intervention Type: DRUG

Placebo

matching placebo administered three times a day

Intervention Type: DRUG

Other Intervention Names

EV product code: PRD4558977, miderizone tablet, ATC:M03BX04

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• pain, inflammation,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Research Develpment and Innovation Fund, Hungary

UNKNOWN

Sponsor Role: collaborator

MEDITOP Pharmaceutical LTD, Hungary

UNKNOWN

Sponsor Role: collaborator

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Bereczki

Professor of neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Bereczki, MD, POhD,DSc

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Locations

Department of Neurology, Semmelweis University

Budapest, , Hungary

Countries

Hungary

Other Identifiers

LOWBACK-SE-01

Identifier Type: -

Identifier Source: org_study_id