Investigation of Peripheral Afferents' Role in Modulating Central Neuropathic Pain Post-Stroke

The primary objective of the study titled "APEDOC: The role of peripheral afferents in modulating post-stroke central pain" is to investigate the role of **peripheral afferents** in the modulation of central neuropathic pain in patients who have experienced a stroke. Understanding this relationship is clinically significant as it may provide insights into potential therapeutic targets for managing post-stroke central pain, a condition that can significantly impact the quality of life and functional recovery in affected individuals.

The clinical trial involves **patients with central neuropathic pain post-stroke**. The study population includes both male and female participants, with an age range that spans from young adults to older adults. The trial does not focus on a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their medical condition, and no specific lifestyle considerations such as diet or physical activity were highlighted. The trial population was chosen to ensure a representative sample of individuals affected by this condition, although specific inclusion or exclusion criteria were not detailed by the sponsor.

The clinical trial is designed to investigate the role of peripheral afferents in modulating **central neuropathic pain** post-stroke. The study is structured as a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thus minimizing bias. The trial is set to commence recruitment on September 25, 2023, and is expected to conclude by October 24, 2025, providing a comprehensive evaluation period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough evaluation to confirm the presence of central neuropathic pain following a stroke. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' progress, assess the efficacy and safety of the intervention, and collect data on primary and secondary endpoints. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather comprehensive data for analysis.

The expected length of participant involvement in the trial is approximately two years, aligning with the overall trial duration. Participants may be subject to early termination from the study if they experience adverse events that compromise their safety, fail to adhere to the study protocol, or withdraw consent. The trial is conducted in accordance with ethical guidelines and regulatory requirements, ensuring the integrity and reliability of the research findings.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for both experimental and non-experimental treatments is not available in the provided data.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized under phase 5, indicating a focus on post-marketing surveillance to gather additional information on the drug's effectiveness and safety in a larger population. The trial is scheduled to commence recruitment on September 25, 2023, with an estimated completion date of October 24, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely employ standard methodologies appropriate for its phase to measure and analyze outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, depending on the nature of the medical condition being studied. The trial will adhere to rigorous data collection and analysis protocols to ensure the reliability and validity of the efficacy assessments.