Evaluation of ODM-111 Efficacy and Tolerability in Chronic Pain Management for Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Trial

The primary objective of this study is to evaluate the **efficacy** of ODM-111 in the treatment of chronic pain due to diabetic peripheral neuropathy (DPN). This is clinically relevant as DPN is a common complication of diabetes, often leading to significant pain and reduced quality of life. Effective management of this pain is crucial for improving patient outcomes and daily functioning.

Secondary objectives include assessing the **tolerability** of ODM-111, which is important for determining the safety profile and potential side effects of the treatment, ensuring that it is a viable option for long-term management of chronic pain in patients with DPN.

The clinical trial investigating the efficacy of ODM-111 in the treatment of **chronic pain due to diabetic peripheral neuropathy** involves a total of 49 participants. The study population comprises both male and female subjects, aged between 18 and 80 years, who have been diagnosed with either Type 1 or Type 2 diabetes for at least six months. Participants are required to have optimized and stable glycemic control for the three months preceding the screening. The trial includes individuals with a diagnosis of painful diabetic peripheral neuropathy, specifically with pain persisting for a minimum of six months, primarily affecting the lower extremities. The selection criteria ensure that participants have a body mass index (BMI) ranging from 18 to 45 kg/m². Lifestyle considerations include adherence to a highly effective form of contraception for participants with partners of child-bearing potential, if applicable. The trial population was selected based on these criteria to ensure a representative sample of individuals experiencing chronic pain due to diabetic peripheral neuropathy.

The clinical trial is designed to evaluate the efficacy and tolerability of **ODM-111** in the treatment of chronic pain due to diabetic peripheral neuropathy. This is a Phase 2, randomized, double-blind, placebo-controlled trial. The trial will involve the administration of **ODM-111** or a placebo, with the primary objective being the assessment of the change in weekly average daily pain intensity from baseline to week 6, as measured by an 11-point numeric rating scale (NRS). The trial is expected to commence recruitment on November 1, 2024, and conclude by February 28, 2026.

Participants will be involved in the study for a maximum treatment period of 6 weeks. The study will include several key visits: an initial screening visit to confirm eligibility, a baseline visit to establish initial pain levels, and subsequent follow-up visits to monitor progress and collect data. The end-of-study visit will occur at the conclusion of the 6-week treatment period. Participants will be required to maintain a stable glycaemic control and adhere to specific contraceptive measures if applicable. The inclusion criteria specify that participants must be between 18 and 80 years of age, have a body mass index (BMI) between 18-45 kg/m², and have a diagnosis of painful diabetic peripheral neuropathy with pain persisting for at least 6 months prior to the screening visit.

Participants may be terminated early from the study if they experience adverse effects, fail to comply with the study protocol, or withdraw consent. The trial will utilize **Para-Tabs 500 mg** as an auxiliary medication, with the primary investigational product being **ODM-111**. The study will ensure that all participants are blinded to the treatment allocation to maintain the integrity of the trial results. The trial's primary endpoint is the change in pain intensity, while secondary endpoints will be evaluated as necessary. The trial will be conducted in accordance with ethical guidelines and regulatory requirements to ensure participant safety and data validity.

The clinical trial involves the evaluation of **ODM-111**, an investigational medication, for the treatment of chronic pain due to diabetic peripheral neuropathy. **ODM-111** is administered in the form of tablets, with the active substance also named **ODM-111**. The pharmaceutical form is oral tablets, and the medication is produced by Orion Corporation. The maximum treatment period for **ODM-111** is six months. The specific dosage and frequency of administration are not detailed in the provided data.

In addition to the experimental medication, the trial includes the use of a placebo, referred to as **ODM-111 Placebo**. The placebo is utilized to serve as a comparator treatment to assess the efficacy of **ODM-111**. The placebo does not contain any active substance and is administered in a manner consistent with the experimental medication to maintain blinding in the study.

Furthermore, the trial incorporates the use of **Para-Tabs 500 mg tabletti**, which contains **paracetamol** as the active substance. This medication is provided in tablet form and is administered orally. The maximum daily dose of **Para-Tabs** is 3 grams, with a total maximum dose of 126 grams over the treatment period. The role of **Para-Tabs** in the trial is auxiliary, and it is also produced by Orion Corporation. The administration of **Para-Tabs** is intended to manage any additional pain symptoms that may arise during the trial.

The efficacy of ODM-111 in the treatment of chronic pain due to diabetic peripheral neuropathy will be assessed using a primary efficacy endpoint. This endpoint is defined as the change from baseline to week 6 in the weekly average of daily pain intensity, measured over the previous 24 hours, on an 11-point numeric rating scale (NRS). Participants will report their pain intensity daily using an electronic diary (eDiary), which will facilitate the collection and analysis of data. The NRS is a validated tool commonly used in clinical trials to quantify pain levels, providing a reliable measure of symptom improvement.