Low Back PainPhase 3BETANCT05544656
The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain and Sciatic Pain "BETA"
A Phase 3 study testing Tolperisone Hydrochloride in people with Low Back Pain, run by Semmelweis University at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Tolperisone Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteHungary
- Study dates
- 13 Dec 2019to 30 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy pain-free volunteers (n=30) outside of the randomized study, will participate to establish normal values of blood biomarkers.
Who cannot join
- pain, inflammation,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain -BETA. A Phase 3 Investigator Initiated Study
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.
Read the 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
- Being tested
- Tolperisone Hydrochloride, Placebo
- Keywords
- back pain, sciatic pain, biomarkers
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolperisone HydrochlorideDrug
Also called EV product code: PRD4558977, miderizone tablet, ATC:M03BX04
Tolperisone Hydrochloride tablets of 150 mg, administered three times a day
PlaceboDrug
matching placebo administered three times a day
| Study group | Role | What they receive |
|---|---|---|
| Tolperisone | Experimental | Tolperisone 3 times 150 mg daily, i.e. a daily dose of 450 mg. Treatment lasts for 14 days Receives: Drug: Tolperisone Hydrochloride |
| Placebo | Placebo comparator | Matching placebo 3 times daily. Treatment lasts for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Subgroup analysis of the change in biomarkers restricted to those with ceased or greatly reduced pain
Measured: 14 days
Change in the intensity of pain by the end of the treatment period
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)
Measured: 14 days
Change in the level of biomarkers enlisted in Primary Outcome 1 by the end of the treatment period in the tolperisone group
Subgroup analysis of changes in blood, electrophysiological and ultrasound biomarkers by 14 days in the tolperisone group
Measured: 14 days
Change in the level of paravertebral muscle contraction by the end of the treatment period
Analysis restricted to the electrophysiological and ultrasound biomarkers enlisted in Primary Outcome 1
Measured: 14 days
Predictive value of the initial levels of biomarkers enlisted in Primary Outcome 1
Evaluation of the association of the initial biomarker values enlisted in Primary Outcome 1 with the 14-day pain features
Measured: 14 days
Global impression of change by the patient
Patient self evaluation of changes by the end of treatment on a 6-grade scale (has become symptom-free; major improvement; minor improvement; no change; minor worsening; major worsening)
Measured: 14 days
Global clinical impression of change (GCI) by the investigator
Subjective evaluation of changes by the end of treatment on a 6-grade scale by the investigator (has become symptom-free; major improvement; minor improvement; no change; minor worsening; major worsening)
Measured: 14 days
Number of participants with treatment-related adverse events
Any adverse events reported during the 14 days of treatment and the 7-day post-treatment period
Measured: 21 days (14 days treatment plus 7 days post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start13 Dec 2019
- Primary completion31 Dec 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, randomized double blind study. Randomization is done separately for those with and those without radicular signs.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research, Development and Innovation Office, Hungary, MEDITOP Pharmaceutical LTD, Hungary
- Responsible party
- Principal investigator, Daniel Bereczki, Semmelweis University
- Investigators
- Daniel Bereczki, MD, POhD,DSc, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544656
- Sponsor's protocol ID
- LOWBACK-SE-01
- Acronym
- BETA
- Status last verified
- Apr 2024
- First submitted
- 8 Aug 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After trial completion the investigators will be ready to share data with other researchers based on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain -BETA. A Phase 3 Investigator Initiated Study
- ClinicalTrials.gov ID
- NCT05544656
- Acronym / sponsor ID
- BETA / LOWBACK-SE-01
- Conditions
- Low Back Pain
- Keywords
- back pain, sciatic pain, biomarkers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- National Research, Development and Innovation Office, Hungary, MEDITOP Pharmaceutical LTD, Hungary
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, randomized double blind study. Randomization is done separately for those with and those without radicular signs.
| Arm | Type | Receives |
|---|---|---|
| Tolperisone | Experimental | Drug: Tolperisone HydrochlorideTolperisone 3 times 150 mg daily, i.e. a daily dose of 450 mg. Treatment lasts for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo 3 times daily. Treatment lasts for 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy pain-free volunteers (n=30) outside of the randomized study, will participate to establish normal values of blood biomarkers.
Key exclusion criteria (1 listed)
- pain, inflammation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tolperisone HydrochlorideAlso: EV product code: PRD4558977, miderizone tablet, ATC:M03BX04Tolperisone Hydrochloride tablets of 150 mg, administered three times a day | Drug | Tolperisone |
| Placebomatching placebo administered three times a day | Drug | Placebo |
Primary outcome
Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values.
Time frame: 14 days
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)
Patient reported change in pain features
Time frame: daily for 14 days
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)
8 secondary outcomes
Change in the level of biomarkers enlisted in Primary Outcome 1 in the subgroup of those with ceased or greatly reduced pain
Time frame: 14 days
Change in the intensity of pain by the end of the treatment period
Time frame: 14 days
Change in the level of biomarkers enlisted in Primary Outcome 1 by the end of the treatment period in the tolperisone group
Time frame: 14 days
Change in the level of paravertebral muscle contraction by the end of the treatment period
Time frame: 14 days
Predictive value of the initial levels of biomarkers enlisted in Primary Outcome 1
Time frame: 14 days
Global impression of change by the patient
Time frame: 14 days
Global clinical impression of change (GCI) by the investigator
Time frame: 14 days
Number of participants with treatment-related adverse events
Time frame: 21 days (14 days treatment plus 7 days post-treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Yes. After trial completion the investigators will be ready to share data with other researchers based on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Bereczki, MD, POhD,DSc principal investigator
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tolperisone Hydrochloride in people with Low Back Pain, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values. (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.