Trial Condition(s):

Neuropathic pain associated with diabetic peripheral neuropathy

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

Bayer Identifier:

20887

ClinicalTrials.gov Identifier:

NCT04641273

EudraCT Number:

2020-002066-14

Terminated/Withdrawn

Trial Purpose

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.
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.

Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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 Summary

Enrollment Goal
154
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Aalborg Universitetshospital

Aalborg, Denmark, 9000

Status
Completed
 
Locations

Steno Diabetes Center Copenhagen

Herlev, Denmark, 2730

Status
Completed
 
Locations

Holbæk Sygehus

Holbæk, Denmark, 4300

Status
Completed
 
Locations

Medect Clinical Trials AB

Stockholm, Sweden, 11526

Status
Terminated
 
Locations

St. Josefskrankenhaus

Heidelberg, Germany, 69115

Status
Terminated
 
Locations

InnoDiab Forschung GmbH

Essen, Germany, 45136

Status
Terminated
 
Locations

Praxis Hr. Dr. med. Jens Taggeselle

Markkleeberg, Germany, 04416

Status
Terminated
 
Locations

Siteworks GmbH

Hannover, Germany, 30449

Status
Terminated
 
Locations

DKD Helios Klinik Wiesbaden

Wiesbaden, Germany, 65191

Status
Terminated
 
Locations

Friedrich-Schiller-Uni. Jena

Jena, Germany, 07747

Status
Terminated
 
Locations

Instytut Diabetologii w Warszawie

Warszawa, Poland, 02-117

Status
Completed
 
Locations

Diamond Clinic Specjalistyczne Poradnie Lekarskie

Krakow, Poland, 31-559

Status
Completed
 
Locations

LANDA - Specjalist. Gabinety Lekarskie

Krakow, Poland, 31-156

Status
Completed
 
Locations

Centrum Badan Klinicznych PI-House

Gdansk, Poland, 80-546

Status
Completed
 
Locations

Futuremeds sp. z o. o.

Wroclaw, Poland, 50-088

Status
Completed
 
Locations

Vita Longa Sp. z o.o.

Katowice, Poland, 40-748

Status
Completed
 
Locations

Kolding Sygehus

Kolding, Denmark, 6000

Status
Completed
 
Locations

Oslo universitetssykehus HF, Aker

Oslo, Norway, 0586

Status
Terminated
 
Locations

AKTIMED Helse AS

Hamar, Norway, 2317

Status
Terminated
 
Locations

Oslo Universitetssykehus HF, Ullevål

Oslo, Norway, 0450

Status
Terminated
 
Locations

Diabetologicka a endokrinologicka ambulance, Milan Kvapil

Praha 4, Czech Republic, 149 00

Status
Terminated
 
Locations

Clintrial s.r.o.

Praha 10, Czech Republic, 101 00

Status
Terminated
 
Locations

Diabet2, s.r.o.

Praha 1, Czech Republic, 110 00

Status
Terminated
 
Locations

Vestra Clinics s.r.o.

Rychnov nad Kneznou, Czech Republic, 516 01

Status
Terminated
 
Locations

Diabetologicka a endokrinologicka ambulance, Milan Kvapil,

Pribram, Czech Republic, 261 01

Status
Terminated
 
Locations

NEUROHK s.r.o

Chocen, Czech Republic, 565 01

Status
Terminated
 
Locations

COROMED SMO KFT

Pecs, Hungary, 7623

Status
Completed
 
Locations

MEDISPEKTRUM s.r.o.

Bratislava, Slovakia, 851 04

Status
Terminated
 
Locations

KONZILIUM s.r.o.

Dubnica nad Vahom, Slovakia, 018 41

Status
Terminated
 
Locations

Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu

Liptovsky Mikulas, Slovakia, 03123

Status
Terminated
 
Locations

Tatratrial s. r. o.

Roznava, Slovakia, 04801

Status
Terminated
 
Locations

NEURES, s.r.o.

Krompachy, Slovakia, 053 42

Status
Terminated
 
Locations

Hopital Ambroise Pare

Boulogne billancourt, France, 92104

Status
Terminated
 
Locations

Hopital Carémeau - Nîmes

NIMES cedex 9, France, 30029

Status
Terminated
 
Locations

Hôpital François Mitterrand - Dijon

DIJON, France, 21000

Status
Terminated
 
Locations

Hôpital Lariboisière - Paris

PARIS, France, 75475

Status
Terminated
 
Locations

emovis GmbH

Berlin, Germany, 10629

Status
Terminated
 
Locations

Medamed Studienambulanz GmbH

Leipzig, Germany, 04315

Status
Terminated
 
Locations

Tampereen yliopistollinen sairaala, keskussairaala

Tampere, Finland, 33520

Status
Terminated
 
Locations

Turun yliopistollinen keskussairaala

Turku, Finland, 20520

Status
Terminated
 
Locations

Health Step Finland Oy

Kuopio, Finland, 70100

Status
Terminated
 
Locations

Diagnos Klaukkalan Lääkäriasema

Klaukkala, Finland, 01800

Status
Terminated
 

Trial Design