Neuropathic Pain Associated With Diabetic Peripheral NeuropathyPhase 2NCT05219812
A Study to Learn How Safe BAY2395840 is and How Well it Works in Participants Who Have Diabetic Nerve Pain
A Phase 2 study testing BAY2395840 in people with Neuropathic Pain Associated With Diabetic Peripheral Neuropathy and Peripheral Neuropathic Pain, run by Bayer at 30 sites in 6 countries.
Trial summary
Researchers are looking for a better way to treat people who have diabetic neuropathic pain (DNP), a condition in which diabetes results in pain due to nerve damage. People with diabetes have high blood sugar levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Peripheral Neuropathic Pain, Diabetes Mellitus
- What is being tested?
- BAY2395840
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 30 sitesin 6 countries
- Study dates
- 16 Feb 2022to 21 Nov 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age at the time of signing the informed consent.
- Have documented diagnosis of type 1 OR type 2 diabetes mellitus (DM).
- Have painful distal symmetrical sensorimotor diabetic neuropathy for at least 6 months prior to the screening and confirmed at screening via the modified Toronto Clinical Neuropathy Score with a score of at least 3.
- Weekly mean 24-hour average pain Numeric Rating Scale (NRS) ≥ 4 with adequate variability (not the same score on all daily pain ratings) and compliance (non-missing pain score on at least 6 out of 7 consecutive days) in daily pain recording during the 7-day NRS baseline period.
- Neuropathic pain according to the Douleur Neuropathique 4 Questions (DN4 questionnaire) at screening visit with a score of at least 4 out of 10.
- Participant should be on stable antidiabetic treatment for at least 3 months prior to the screening visit and there should be no pre-planned changes to antidiabetic treatment during this study.
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- Participant is willing to use only rescue medication provided by the site and is willing to withdraw temporarily all other neuropathic pain medications which were in use before study participation.
- Participant is willing and able to use the electronic hand-held device on their own.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Clinically significant cardiovascular or cerebrovascular disease including Acute coronary syndrome (ACS)/myocardial infarction /stroke/Transient ischemic attack (TIA) within previous 3 months before screening visit.
- Major depressive episode within 6 months prior to screening. Patients with stable depression and on stable antidepressant dose (no change in medication and /or dosing regimen) for the past 6 months are allowed to participate, provided the antidepressant used is not listed under prohibited medications.
- Any differential diagnosis of peripheral diabetic neuropathy (PDN) including but not limited to other neuropathies (e.g. vitamin B12 deficiency, Chronic Inflammatory Demyelinating Polyneuropathy), polyradiculopathies, central disorders (e.g. demyelinating disease), or rheumatological disease (e.g. foot arthritis, plantar fasciitis).
- Concurrent malignancy or history of cancer (exception of basal cell or squamous cell carcinoma of the skin) within the last 5 years prior to screening.
- Any other diseases or conditions that according to the investigator can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study intervention (e.g. chronic bowel disease, Crohn's disease, and ulcerative colitis).
- Any serious or unstable diseases or conditions including psychiatric disorders that might interfere with the conduct of the study or the interpretation of the results.
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- Major surgery or radiological procedures (e.g. Percutaneous transluminal angioplasty (PTA) and stenting of peripheral vascular lesions in lower extremities) within 3 months before screening visit or scheduled during the study period, which might interfere pain response evaluation.
- Symptomatic peripheral arterial disease in lower or upper extremities, including diabetic ulcers.
- Use of live, attenuated, replication-competent vaccines.
- Previous use of strong opioids (e.g. oxymorphone, oxycodone) for neuropathic pain anytime, or topical use of capsaicin within 3 months prior to the screening visit.
- History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for study participants.
- Moderate-to-severe hepatic impairment defined as Child-Pugh Class B or C.
- Have platelets ≤ 100 x 109/L, or neutrophil count < 1.2 x 109/L (or equivalent), hemoglobin ≤ 100 g/L for women or hemoglobin ≤ 110 g/L for men at screening.
- Glycemic control unstable (hemoglobin HbA1c ≥11% or 97 mmol/mol) within 3 months prior to screening (e.g. ketoacidosis requiring hospitalization, any recent episode of hypoglycemia requiring assistance through medical intervention, uncontrolled hyperglycemia).
- ALT >2xULN, or AST >2xULN, or total bilirubin greater than ULN, or alkaline phosphatase (AP) >2x ULN, or INR greater than ULN (unless related to anticoagulation treatment) at screening.
- Positive hepatitis B virus surface antigen (HBsAg) or positive hepatitis C virus antibodies (anti-HCV) and detection of mRNA (HCV-mRNA tested only if hepatitis C virus antibodies detected).
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 calculated by Modification of Diet in Renal Disease (MDRD) formula.
- Uncontrolled hypertension despite optimal treatment with antihypertensive(s), indicated by a sitting systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg.
Trial locations and contacts
30 sites in 6 countries.
30 sites in 6 countries
Czechia7 sites
NEUROHK s.r.o
Choceň, 565 01
Interni a diabetologicka ambulance - Krnov
Krnov, 794 01
Fakultni nemocnice Ostrava
Ostrava, 708 52
Vseobecna fakultni nemocnice v Praze
Prague, 12808
Praglandia
Prague, 150 00
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, 516 01
Diabetologicka ambulance Vlasim
Vlašim, 258 01
Germany6 sites
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
Bad Oeynhausen, North Rhine-Westphalia, 32545
Klinische Forschung Berlin GbR
Berlin, 10787
InnoDiab Forschung GmbH
Essen, North Rhine-Westphalia, 45136
Klinische Forschung Hannover-Mitte GmbH
Hanover, Lower Saxony, 30159
Klinische Forschung Karlsruhe GmbH
Karlsruhe, Baden-Wurttemberg, 76137
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, 19055
Slovakia6 sites
ALIAN s.r.o.
Bardejov, 085 01
NEUROPOINT sro, Neurologicka ambulancia
Bratislava, 851 01
Internal and Diabetes Clinic - IN-DIA s.r.o. | Lucenec, Slovakia
Lučenec, 984 01
Vseobecna nemocnica v Ziari nad Hronom
Žiar nad Hronom, 965 37
Neuron - D.T. sro, Neurologicka ambulancia
Žilina, 010 01
Medivasa s.r.o.
Žilina, 01001
Spain5 sites
Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
A Coruña, A Coruña, 15006
Hospital General Universitario de Alicante
Alicante, 03010
Complexo HU Ferrol | Endocrinología y Nutrición
Ferrol, A Coruña, 15405
Hospital Univ. Bellvitge | Anestesiología y Unidad del Dolor
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Gregorio Maranon | Endocrinology Department
Madrid, 28007
Hungary3 sites
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, 8230
Clinexpert Kft.
Budapest, 1033
Coromed Smo Kft
Pécs, 7623
United Kingdom3 sites
King's College Hospital - NHS Foundation Trust
London, SE5 9RS
MAC Research Centre - Manchester
Manchester
MAC Clinical Research - Teesside
Teesside, Stockton-on-Tees, TS17 6EW
About this study
Official title: A Randomized, Double-blind, Cross-over, Placebo-controlled, Multi-center, Phase 2a Study to Assess the Safety and Signal in Efficacy of BAY 2395840 in Patients With Diabetic Neuropathic Pain
Researchers are looking for a better way to treat people who have diabetic neuropathic pain (DNP), a condition in which diabetes results in pain due to nerve damage.
People with diabetes have high blood sugar levels. Over the time, high blood sugar levels can cause damage to the nerves in the body, which results in DNP. The nerve damage in this condition is localized in a stocking and glove like pattern and starts in the feet and can move upwards on your legs. Some patients also progress having pain in their fingers/hands. People with DNP have pain in these areas as well as reduction/loss of feeling, and at times light touch can feel like pain.
Read more
In this study, the researchers want to learn more about a new study treatment called BAY 2395840. BAY 2395840 works by blocking a receptor called the bradykinin B1 receptor, or B1R. This receptor is has been shown to play a role in pain perception.
The researchers also want to learn how well BAY 2395840 helps to reduce pain in the study participants. To answer this question, the researchers will measure how the participants' pain changes after taking BAY 2395840 compared to a placebo. A placebo looks like a treatment but does not have any medicine in it. The researchers also want to learn how safe BAY 2395840 is for the participants to take.
The study will include adults.
This will be a "crossover" study. In a crossover study, all the participants will receive both treatments (BAY 2395840 and placebo), but in a different order. All participants in this study will take BAY 2395840 and a placebo as tablets by mouth.
There will be 2 periods in the study. Participants taking BAY 2395840 during period 1 will switch to placebo during period 2 and vice versa. There will some time for the switch from one period to another to make sure that whatever tablet you received in period 1 is gone from your system before period 2 starts to allow for the best possible evaluation of each tablet without any confusing effects.
The study is double blinded meaning that neither you nor your doctor will know which drug you are on. The sequence of double-blind placebo and BAY treatment will be determined randomly by a computerized system.
During the study, the participants will visit their study site 13 times. Each participant will be in the study for about 16 weeks. The treatment duration will be about 11 weeks.
During the study, the study team will:
- take blood and urine samples
- do physical examinations
- check the participants' overall health
- check the participants' heart health using an electrocardiogram (ECG)
- ask the participants about any medications they have been taking, and what adverse events they are having
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
- Conditions
- Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Peripheral Neuropathic Pain, Diabetes Mellitus
- Being tested
- BAY2395840, Placebo for BAY2395840
- Keywords
- Neuropathic Pain
- Medical subject headings
- Diabetes Mellitus, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2395840Drug
Tablet, intake orally.
Placebo for BAY2395840Drug
Tablet, intake orally.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (BAY2395840 - placebo) | Experimental | Participants will be randomly assigned to treatment regimen of double-blind BAY2395840, and after an interim single blind period for washout will switch to double-blind placebo. Receives: Drug: BAY2395840; Drug: Placebo for BAY2395840 |
| Group 2 (Placebo - BAY2395840) | Experimental | Participants will start with a treatment regimen of double-blind placebo, and after an interim single blind period for washout will switch to double-blind BAY2395840. Receives: Drug: BAY2395840; Drug: Placebo for BAY2395840 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weekly mean 24-hour average pain intensity score using the 11-point Numeric Rating Scale (NRS) from baseline to the end of intervention
NRS is an one-item assessment of average neuropathic pain intensity which is presented as an 11-point Likert scale with 0 as "no pain" and 10 as "worst imaginable pain".
Measured: Baseline to end of intervention (in total up to 16 weeks)
Secondary outcomes (4)
Change in Neuropathic Pain Symptom Inventory (NPSI) score from baseline to the end of intervention.
The Neuropathic Pain Symptom Inventory (NPSI) is a PRO developed to evaluate different symptoms of neuropathic pain.
Measured: At visit 2, visit 4, visit 6, visit 8, visit 10 and at visit 12 end of intervention (EOI).
Change in Patient Global Impression of Severity (PGI-S) score from baseline to the end of intervention.
The PGI-S is a one-item self-reported instrument used to assess to assess patients' impression of disease severity with a 6-point scale response options, scores ranging from 1 ("none") to 6 ("very severe).
Measured: At visit 2, visit 4, visit 6, visit 8, visit 10 and at visit 12 end of intervention (EOI).
The proportion of participants achieving a ≥30% and a ≥50% reduction in weekly mean 24-hour average pain intensity score (i.e. responder rates using NRS)
Measured: From baseline to end of intervention (in total up to 12 weeks)
Number of participants with treatment emergent adverse events (TEAE)
Measured: From start of study intervention to 14 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start16 Feb 2022
- Primary completion7 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic Pain Associated With Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by BayerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219812
- Sponsor's protocol ID
- 19636
- Other IDs
- 2021-001392-17
- Status last verified
- Nov 2023
- First submitted
- 21 Jan 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Stemper B, Lowen S, Fritsch A, Hoffmann A, Sarkar A. The bradykinin-1 receptor antagonist fulmetibant in patients with diabetic neuropathic pain: the randomized, crossover, placebo-controlled, double-blind, phase 2a BRADiNP study. Pain. 2025 Oct 1;166(10):2421-2429. doi: 10.1097/j.pain.0000000000003642. Epub 2025 May 6.
PubMed 40334047
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Cross-over, Placebo-controlled, Multi-center, Phase 2a Study to Assess the Safety and Signal in Efficacy of BAY 2395840 in Patients With Diabetic Neuropathic Pain
- ClinicalTrials.gov ID
- NCT05219812
- Acronym / sponsor ID
- 19636
- Conditions
- Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Peripheral Neuropathic Pain, Diabetes Mellitus
- Keywords
- Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 2 Feb 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.
Researchers are looking for a better way to treat people who have diabetic neuropathic pain (DNP), a condition in which diabetes results in pain due to nerve damage.
People with diabetes have high blood sugar levels. Over the time, high blood sugar levels can cause damage to the nerves in the body, which results in DNP. The nerve damage in this condition is localized in a stocking and glove like pattern and starts in the feet and can move upwards on your legs. Some patients also progress having pain in their fingers/hands. People with DNP have pain in these areas as well as reduction/loss of feeling, and at times light touch can feel like pain.
In this study, the researchers want to learn more about a new study treatment called BAY 2395840. BAY 2395840 works by blocking a receptor called the bradykinin B1 receptor, or B1R. This receptor is has been shown to play a role in pain perception.
The researchers also want to learn how well BAY 2395840 helps to reduce pain in the study participants. To answer this question, the researchers will measure how the participants' pain changes after taking BAY 2395840 compared to a placebo. A placebo looks like a treatment but does not have any medicine in it. The researchers also want to learn how safe BAY 2395840 is for the participants to take.
The study will include adults.
This will be a "crossover" study. In a crossover study, all the participants will receive both treatments (BAY 2395840 and placebo), but in a different order. All participants in this study will take BAY 2395840 and a placebo as tablets by mouth.
There will be 2 periods in the study. Participants taking BAY 2395840 during period 1 will switch to placebo during period 2 and vice versa. There will some time for the switch from one period to another to make sure that whatever tablet you received in period 1 is gone from your system before period 2 starts to allow for the best possible evaluation of each tablet without any confusing effects.
The study is double blinded meaning that neither you nor your doctor will know which drug you are on. The sequence of double-blind placebo and BAY treatment will be determined randomly by a computerized system.
During the study, the participants will visit their study site 13 times. Each participant will be in the study for about 16 weeks. The treatment duration will be about 11 weeks.
During the study, the study team will:
- take blood and urine samples
- do physical examinations
- check the participants' overall health
- check the participants' heart health using an electrocardiogram (ECG)
- ask the participants about any medications they have been taking, and what adverse events they are having
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (BAY2395840 - placebo) | Experimental | Drug: BAY2395840, Drug: Placebo for BAY2395840Participants will be randomly assigned to treatment regimen of double-blind BAY2395840, and after an interim single blind period for washout will switch to double-blind placebo. |
| Group 2 (Placebo - BAY2395840) | Experimental | Drug: BAY2395840, Drug: Placebo for BAY2395840Participants will start with a treatment regimen of double-blind placebo, and after an interim single blind period for washout will switch to double-blind BAY2395840. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults ≥ 18 years of age at the time of signing the informed consent.
- Have documented diagnosis of type 1 OR type 2 diabetes mellitus (DM).
- Have painful distal symmetrical sensorimotor diabetic neuropathy for at least 6 months prior to the screening and confirmed at screening via the modified Toronto Clinical Neuropathy Score with a score of at least 3.
- Weekly mean 24-hour average pain Numeric Rating Scale (NRS) ≥ 4 with adequate variability (not the same score on all daily pain ratings) and compliance (non-missing pain score on at least 6 out of 7 consecutive days) in daily pain recording during the 7-day NRS baseline period.
- Neuropathic pain according to the Douleur Neuropathique 4 Questions (DN4 questionnaire) at screening visit with a score of at least 4 out of 10.
Key exclusion criteria (18 listed)
- Clinically significant cardiovascular or cerebrovascular disease including Acute coronary syndrome (ACS)/myocardial infarction /stroke/Transient ischemic attack (TIA) within previous 3 months before screening visit.
- Major depressive episode within 6 months prior to screening. Patients with stable depression and on stable antidepressant dose (no change in medication and /or dosing regimen) for the past 6 months are allowed to participate, provided the antidepressant used is not listed under prohibited medications.
- Any differential diagnosis of peripheral diabetic neuropathy (PDN) including but not limited to other neuropathies (e.g. vitamin B12 deficiency, Chronic Inflammatory Demyelinating Polyneuropathy), polyradiculopathies, central disorders (e.g. demyelinating disease), or rheumatological disease (e.g. foot arthritis, plantar fasciitis).
- Concurrent malignancy or history of cancer (exception of basal cell or squamous cell carcinoma of the skin) within the last 5 years prior to screening.
- Any other diseases or conditions that according to the investigator can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study intervention (e.g. chronic bowel disease, Crohn's disease, and ulcerative colitis).
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 |
|---|---|---|
| BAY2395840Tablet, intake orally. | Drug | Group 1 (BAY2395840 - placebo), Group 2 (Placebo - BAY2395840) |
| Placebo for BAY2395840Tablet, intake orally. | Drug | Group 1 (BAY2395840 - placebo), Group 2 (Placebo - BAY2395840) |
Primary outcome
Change in weekly mean 24-hour average pain intensity score using the 11-point Numeric Rating Scale (NRS) from baseline to the end of intervention
Time frame: Baseline to end of intervention (in total up to 16 weeks)
NRS is an one-item assessment of average neuropathic pain intensity which is presented as an 11-point Likert scale with 0 as "no pain" and 10 as "worst imaginable pain".
4 secondary outcomes
Change in Neuropathic Pain Symptom Inventory (NPSI) score from baseline to the end of intervention.
Time frame: At visit 2, visit 4, visit 6, visit 8, visit 10 and at visit 12 end of intervention (EOI).
Change in Patient Global Impression of Severity (PGI-S) score from baseline to the end of intervention.
Time frame: At visit 2, visit 4, visit 6, visit 8, visit 10 and at visit 12 end of intervention (EOI).
The proportion of participants achieving a ≥30% and a ≥50% reduction in weekly mean 24-hour average pain intensity score (i.e. responder rates using NRS)
Time frame: From baseline to end of intervention (in total up to 12 weeks)
Number of participants with treatment emergent adverse events (TEAE)
Time frame: From start of study intervention to 14 days after last dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 40334047Stemper B, Lowen S, Fritsch A, Hoffmann A, Sarkar A. The bradykinin-1 receptor antagonist fulmetibant in patients with diabetic neuropathic pain: the randomized, crossover, placebo-controlled, double-blind, phase 2a BRADiNP study. Pain. 2025 Oct 1;166(10):2421-2429. doi: 10.1097/j.pain.0000000000003642. Epub 2025 May 6.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY2395840 in people with Neuropathic Pain Associated With Diabetic Peripheral Neuropathy and Peripheral Neuropathic Pain, run by Bayer at 30 sites in 6 countries.
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 9 inclusion and 18 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: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Czechia, Germany, Slovakia, Spain, Hungary and 1 more country. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 weekly mean 24-hour average pain intensity score using the 11-point Numeric Rating Scale (NRS) from baseline to the end of intervention (time frame: Baseline to end of intervention (in total up to 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219812, which also lists 1 linked publication.
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 13 Nov 2023.