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Study on the Effectiveness of ODM-111 and Paracetamol for Chronic Pain in Patients with Diabetic Peripheral Neuropathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a new medication called ODM-111 for treating chronic pain due to diabetic peripheral neuropathy. Diabetic peripheral neuropathy is a condition that affects the nerves, often causing pain in the legs and feet, and is a common complication of diabetes. The study will compare the effects of ODM-111 with a placebo to understand how well the medication works in reducing pain.

The purpose of the study is to evaluate how effective ODM-111 is in managing pain associated with diabetic peripheral neuropathy. Participants in the study will receive either ODM-111 or a placebo, and their pain levels will be monitored over a period of six weeks. The medication is taken orally in the form of tablets. Throughout the study, participants will be asked to record their daily pain levels using a simple numerical scale to help researchers assess any changes in pain intensity.

In addition to ODM-111, the study will also involve the use of Para-Tabs, which contain paracetamol, a common pain reliever. The study aims to provide valuable information on the potential benefits of ODM-111 for individuals suffering from chronic pain due to diabetic peripheral neuropathy, with the hope of improving treatment options for this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, participants will attend an initial visit. During this visit, participants will receive detailed information about the study and will be asked to provide signed informed consent to confirm their willingness to participate.

    Participants will undergo a screening process to ensure they meet the study's eligibility criteria, which includes age, body mass index, and a diagnosis of diabetic peripheral neuropathy with chronic pain.

  2. Step 2

    Baseline assessment

    Participants will complete a baseline assessment, which involves recording their average pain intensity using an 11-point numeric rating scale. This assessment will be based on daily pain evaluations over at least five of the seven days preceding the baseline visit.

  3. Step 3

    Treatment phase

    Participants will begin the treatment phase, which involves taking the study medication, ODM-111, in tablet form. The medication is administered orally.

    The dosage and frequency of ODM-111 will be determined by the study protocol, and participants will be required to take the medication as instructed for the duration of the study.

  4. Step 4

    Ongoing assessments

    Throughout the study, participants will be asked to maintain a daily electronic diary (eDiary) to record their pain intensity over the previous 24 hours. This information will be used to evaluate the effectiveness of the treatment.

    Participants will attend regular follow-up visits to monitor their progress and any potential side effects of the medication.

  5. Step 5

    End of study

    At the end of the study, participants will undergo a final assessment to evaluate changes in their pain levels and overall health.

    Participants will be provided with information on how to safely discontinue the study medication and any necessary follow-up care.

Who can join the trial?

9 criteria

  • Signed informed consent to participate in the trial.
  • Men and women aged between 18 and 80 years at the time of the screening visit.
  • Body Mass Index (BMI) between 18 and 45 kg/m2 at the screening visit. BMI is a measure of body fat based on height and weight.
  • Have Type 1 or Type 2 diabetes for at least 6 months with well-controlled blood sugar levels for the 3 months before the screening.
  • Diagnosed with painful diabetic peripheral neuropathy (DPN) for at least 6 months before the screening visit, with pain mainly in the legs.
  • An average pain intensity of a certain level on a scale from 0 to 10 in the legs during the past 24 hours at screening and at the start of the study.
  • A weekly average of daily pain intensity on a scale from 0 to 10 at the start of the study, based on daily assessments over at least 5 of the 7 days before the start of the study.
  • A Douleur Neuropathique 4 (DN4) score of a certain level at the screening visit. The DN4 is a questionnaire used to assess nerve pain.
  • Female participants with male partners who can have children and male participants with female partners who can have children must use a highly effective form of birth control if sexually active and not permanently sterilized. This applies to females from 4 weeks before the first study treatment and to males from the first day of treatment until 3 months after the end of the study. Women who have not had a menstrual cycle for 1 year are considered not able to have children and can be included. Male participants cannot donate sperm until 3 months after the end of the study.

Who cannot join the trial?

9 criteria

  • Patients who do not have chronic pain due to diabetic peripheral neuropathy cannot participate. This means the study is only for those who have nerve pain caused by diabetes.
  • Patients who are not within the specified age range cannot participate. The study is for adults only.
  • Patients who are not willing to follow the study procedures cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with other serious health conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent surgery or are planning to have surgery during the study period cannot participate.
  • Patients with a history of substance abuse cannot participate.
  • Patients who have allergies to the study medication or its ingredients cannot participate.
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Investigated drugs

ODM-111 is a medication being studied for its ability to help manage chronic pain caused by diabetic peripheral neuropathy. This condition is a type of nerve damage that can occur in people with diabetes, leading to pain, tingling, or numbness, usually in the feet and hands. The goal of using ODM-111 in this trial is to see if it can effectively reduce the pain associated with this nerve damage and improve the quality of life for those affected. The study also aims to assess how well patients tolerate the medication, meaning how it affects them and whether it causes any side effects. By participating in this trial, patients help researchers understand if ODM-111 could be a useful treatment option for managing chronic pain due to diabetic peripheral neuropathy.

What is already known about the treatment

ODM-111 – ODM-111 is administered orally in the form of tablets and is currently being studied for its effectiveness in treating chronic pain caused by diabetic peripheral neuropathy. This medication is still under investigation, and its full status in medical literature is not yet established, as it is part of ongoing clinical trials. The main therapeutic indication for ODM-111 is to alleviate chronic pain associated with nerve damage due to diabetes. At the molecular level, ODM-111 works by modulating specific pathways in the nervous system to reduce pain signals. It is classified pharmacologically as an analgesic, which means it is designed to relieve pain.

Investigated diseases

Chronic Pain Due to Diabetic Peripheral Neuropathy – Diabetic Peripheral Neuropathy is a condition that affects the nerves in the extremities, primarily the feet and legs, due to prolonged high blood sugar levels. This nerve damage can lead to chronic pain, which is persistent and can vary in intensity. The pain is often described as burning, tingling, or sharp, and it can significantly impact daily activities and quality of life. Over time, the condition may lead to increased sensitivity to touch or even numbness in the affected areas. The progression of nerve damage can be gradual, and symptoms may worsen if blood sugar levels are not well controlled.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513595-17-00Protocol code3133004Estimated enrolment252 patientsSponsorOrion Corporation

sourced from the EU Clinical Trials Register and site verification

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