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Neuropathic Pain Associated With Diabetic Peripheral NeuropathyPhase 2NCT04641273

A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants With Diabetic Neuropathic Pain

A Phase 2 study testing BAY1817080 and Pregabalin in people with Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, run by Bayer at 42 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

People suffering from diabetes often have high blood sugar levels. Over time this can affect many organs including the nerves in hands and feet and can cause a nerve pain called diabetic neuropathic pain (DNP). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BAY1817080 and Pregabalin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
42 sitesin 10 countries
Study dates
22 Jan 2021to 18 Oct 2021
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.
  • At the time of screening, have documented diagnosis of type 1 OR type 2 diabetes mellitus (DM) with painful distal symmetrical sensorimotor neuropathy of more than 6 months duration according to modified Toronto Clinical Neuropathy Score.
  • Weekly mean 24-hour average pain 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 DN4 questionnaire (Douleur Neuropathique 4 Questions).
  • Women of childbearing potential must agree to use acceptable effective or highly effective birth control methods.

Who cannot join

  • 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).
  • 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.
  • Major surgery or radiological procedures (e.g. PTA (Percutaneous transluminal angioplasty) 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.
  • 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.
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  • 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%) 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) >2xULN, 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 (local formulas will be used where applicable.
  • 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

42 sites in 10 countries.

42 sites in 10 countries

Germany8 sites

  • emovis GmbH

    Berlin, 10629

  • InnoDiab Forschung GmbH

    Essen, North Rhine-Westphalia, 45136

  • Siteworks GmbH

    Hanover, Lower Saxony, 30449

  • St. Josefskrankenhaus

    Heidelberg, Baden-Wurttemberg, 69115

  • Friedrich-Schiller-Uni. Jena

    Jena, Thuringia, 07747

  • Medamed Studienambulanz GmbH

    Leipzig, Saxony, 04315

  • Praxis Hr. Dr. med. Jens Taggeselle

    Markkleeberg, Saxony, 04416

  • DKD Helios Klinik Wiesbaden

    Wiesbaden, 65191

Other trials in Germany

Czechia6 sites

  • NEUROHK s.r.o

    Choceň, 565 01

  • Clintrial s.r.o.

    Prague, 101 00

  • Diabet2, s.r.o.

    Prague, 110 00

  • Diabetologicka a endokrinologicka ambulance, Milan Kvapil

    Prague, 149 00

  • Diabetologicka a endokrinologicka ambulance, Milan Kvapil,

    Příbram, 261 01

  • Vestra Clinics s.r.o.

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Poland6 sites

  • Centrum Badan Klinicznych PI-House

    Gdansk, 80-546

  • Vita Longa Sp. z o.o.

    Katowice, 40-748

  • LANDA - Specjalist. Gabinety Lekarskie

    Krakow, 31-156

  • Diamond Clinic Specjalistyczne Poradnie Lekarskie

    Krakow, 31-559

  • Instytut Diabetologii w Warszawie

    Warsaw, 02-117

  • Futuremeds sp. z o. o.

    Wroclaw, 50-088

Other trials in Poland

Slovakia5 sites

  • MEDISPEKTRUM s.r.o.

    Bratislava, 851 04

  • KONZILIUM s.r.o.

    Dubnica nad Váhom, 018 41

  • NEURES, s.r.o.

    Krompachy, 053 42

  • Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu

    Liptovský Mikuláš, 03123

  • Tatratrial s. r. o.

    Rožňava, 04801

Other trials in Slovakia

Denmark4 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Steno Diabetes Center Copenhagen

    Herlev, 2730

  • Holbæk Sygehus

    Holbæk, 4300

  • Kolding Sygehus

    Kolding, 6000

Other trials in Denmark

Finland4 sites

  • Diagnos Klaukkalan Lääkäriasema

    Klaukkala, 01800

  • Health Step Finland Oy

    Kuopio, 70100

  • Tampereen yliopistollinen sairaala, keskussairaala

    Tampere, 33520

  • Turun yliopistollinen keskussairaala

    Turku, 20520

Other trials in Finland

France4 sites

  • Hopital Ambroise Pare

    Boulogne-Billancourt, 92104

  • Hôpital François Mitterrand - Dijon

    Dijon, 21000

  • Hopital Carémeau - Nîmes

    Nîmes, 30029

  • Hôpital Lariboisière - Paris

    Paris, 75475

Other trials in France

Norway3 sites

  • AKTIMED Helse AS

    Hamar, 2317

  • Oslo Universitetssykehus HF, Ullevål

    Oslo, 0450

  • Oslo universitetssykehus HF, Aker

    Oslo, 0586

Other trials in Norway

Hungary1 site

  • Coromed Smo Kft

    Pécs, 7623

Other trials in Hungary

Sweden1 site

  • Medect Clinical Trials AB

    Stockholm, 11526

Other trials in Sweden

About this study

Official title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Combined Phase 2a/2b Study to Assess the Efficacy and Safety of BAY 1817080 in Patients With Diabetic Neuropathic Pain

People suffering from diabetes often have high blood sugar levels. Over time this can affect many organs including the nerves in hands and feet and can cause a nerve pain called diabetic neuropathic pain (DNP). There are treatments for DNP but in many patients they do not reach a good pain reduction and have unwanted side effects.

In this trial, the researchers will look at how BAY1817080 works and how safe it is. They will compare it to a placebo or another treatment for DNP called pregabalin. A placebo looks like a treatment but does not have any medicine in it. The researchers will use a placebo to learn if the participants' results are due to BAY1817080 or if the results could be due to chance. The researchers will also learn more about the right dose of BAY1817080 for these participants.

Read more

The trial will include participants who have DNP and either type 1 or type 2 diabetes. It will include about 440 men and women who are at least 18 years old.

This trial will have 2 parts. In Part 1, the participants will take either BAY1817080 or the placebo. These treatments will be taken as a tablet by mouth twice a day for 8 weeks. In Part 2, participants will take BAY 1817080, pregabalin, or a matching placebo of either treatment. BAY1817080 and a placebo will be taken as a tablet by mouth twice a day for 12 weeks. Pregabalin and a placebo will be taken as a capsule by mouth twice a day for 12 weeks.

The participants in Part 1 will visit their trial site 6 times. The participants in Part 2 will visit their trial site 7 times. At these visits, the doctors will ask the participants if they have any health problems, take blood samples, and do a physical exam. They will also ask the participants to complete questionnaires about their pain and other symptoms.

Being tested
BAY1817080, Placebo for BAY1817080, Placebo for Pregabalin, Pregabalin
Keywords
Diabetic Neuropathic Pain, Neuropathic Pain, Diabetic Polyneuropathy
Medical subject headings
Neuralgia, Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY1817080Drug

    Tablet, intake orally.

  • Placebo for BAY1817080Drug

    Tablet, intake orally.

  • Placebo for PregabalinDrug

    Capsule, intake orally.

  • PregabalinDrug

    Capsule, intake orally. Starting dose 75 mg BID first week, increase to 150 mg BID in second week.

Study groups in NCT04641273
Study groupRoleWhat they receive
Part A: BAY1817080 150 mg BIDExperimentalIn Part A, Participants will be randomized to this arm with BAY1817080 150 mg BID.
Receives: Drug: BAY1817080
Part A: Placebo BIDPlacebo comparatorIn Part A, Participants will be randomized to this arm with placebo for BAY1817080.
Receives: Drug: Placebo for BAY1817080
Part B: BAY1817080 25 mg BIDExperimentalIn Part B, New participants will be screened for this part of the study and will be randomized to this arm with BAY1817080 25 mg BID and placebo for pregabalin.
Receives: Drug: BAY1817080; Drug: Placebo for Pregabalin
Part B: BAY1817080 75 mg BIDExperimentalIn Part B, New participants will be screened for this part of the study and will be randomized to this arm with BAY1817080 75 mg BID and placebo for pregabalin.
Receives: Drug: BAY1817080; Drug: Placebo for Pregabalin
Part B: BAY1817080 150 mg BIDExperimentalIn Part B, New participants will be screened for this part of the study and will be randomized to this arm with BAY1817080 150 mg BID and placebo for pregabalin.
Receives: Drug: BAY1817080; Drug: Placebo for Pregabalin
Part B: Placebo BIDPlacebo comparatorIn Part B, New participants will be screened for this part of the study and will be randomized to this arm with placebo for BAY1817080 and placebo for pregabalin.
Receives: Drug: Placebo for BAY1817080; Drug: Placebo for Pregabalin
Part B: PregabalinActive comparatorIn Part B, New participants will be screened for this part of the study and will be randomized to this arm with placebo for BAY1817080 and pregabalin.
Receives: Drug: Placebo for BAY1817080; Drug: Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Part A: from baseline to end of intervention (in total up to 9 weeks)

  2. 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: Part B: from baseline to end of intervention (in total up to 13 weeks)

Secondary outcomes (4)

  1. 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: Part A: at visit 2, visit 4 (day 15 +/- 2), visit 5 (day 29 +/-2) and visit 7 EOI (day 57 +/-2). Part B: at visit 2, visit 4 (day 15 +/- 2), visit 5 (day 29 +/-2), visit 7 (day 57 +/-2) and visit 8 EOI (day 85 +/-2).

  2. Patient Global Impression of Change (PGI-C) at the end of intervention

    The PGI-C is an one-item, self-reported instrument used to assess patients' impression of disease severity and change, with a 7-point scale response-option. Scores range from 1 ("very much better") to 7 ("very much worse").

    Measured: Part A: at visit 5 (day 29 +/-2) and at end of intervention (day 57 +/- 2). Part B: at visit 5 (day 29 +/-2), at visit 7 (day 57 +/- 2) and at end of intervention (day 85 +/-2)

  3. 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: Part A: from baseline to end of intervention (in total up to 9 weeks). Part B: from baseline to end of intervention (in total up to 13 weeks)

  4. Number of participants with treatment emergent adverse events (TEAE)

    Measured: Start of intervention to 14 days after stop of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start22 Jan 2021
  3. Primary completion23 Sep 2021
  4. Study completion18 Oct 2021

Why it stopped: Lack of efficacy

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04641273
Sponsor's protocol ID
20887
Other IDs
2020-002066-14
Status last verified
Dec 2022
First submitted
20 Nov 2020
Last updated
12 Dec 2022
Results posted
No
Data monitoring committee
No
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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

Publications

  • Bouhassira D, Tesfaye S, Sarkar A, Soisalon-Soininen S, Stemper B, Baron R. Efficacy and safety of eliapixant in diabetic neuropathic pain and prediction of placebo responders with an exploratory novel algorithm: results from the randomized controlled phase 2a PUCCINI study. Pain. 2024 Apr 1;165(4):785-795. doi: 10.1097/j.pain.0000000000003085. Epub 2023 Oct 18.

    PubMed 37851336

  • Fletcher MC. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis. Purinergic Signal. 2022 Mar;18(1):1-3. doi: 10.1007/s11302-021-09831-5. Epub 2022 Jan 3. No abstract available.

    PubMed 34978027

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY1817080 and Pregabalin in people with Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, run by Bayer at 42 sites in 10 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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Germany, Czechia, Poland, Slovakia, Denmark and 5 more countries. 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 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 was stopped early (reason given: Lack of efficacy). 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 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: Part A: from baseline to end of intervention (in total up to 9 weeks)). 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?

On the ClinicalTrials.gov record for NCT04641273, which also lists 2 linked publications.

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 12 Dec 2022.

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