Phase 2 Evaluation of Ifenprodil for Remyelination in Multiple Sclerosis Patients

The primary objective of this phase 2 trial is to evaluate the efficacy of **Ifenprodil** as a repurposed drug for remyelination in patients with **Multiple Sclerosis**. This study aims to determine whether Ifenprodil can promote the repair of myelin, the protective sheath around nerve fibers, which is often damaged in multiple sclerosis. The clinical relevance of this objective lies in addressing the unmet need for therapies that can repair myelin and potentially improve neurological function in affected individuals.

The clinical trial focuses on individuals diagnosed with **multiple sclerosis**. The study population includes both male and female participants, with an age range categorized under code "3", which typically represents adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants involved in the study. Participants were selected without any specified lifestyle considerations such as diet, physical activity, or habits. Key inclusion or exclusion criteria have not been disclosed by the sponsor.

The clinical trial is designed to evaluate the efficacy of **Ifenprodil** as a remyelinating agent in patients with **multiple sclerosis**. This study is structured as a phase 2, randomized, double-blind, controlled trial. The trial is expected to commence recruitment on December 1, 2023, and is projected to conclude by February 14, 2027. Participants will be randomly assigned to either the treatment group receiving Ifenprodil or a control group, with neither the participants nor the investigators aware of the group assignments to maintain blinding.

The sequence of study visits begins with an inclusion visit, where potential participants undergo screening to determine eligibility based on predefined criteria. Following successful inclusion, participants will attend regular follow-up visits at specified intervals to monitor their health status, assess treatment efficacy, and record any adverse events. The trial will culminate in an end-of-study visit, where final assessments will be conducted to evaluate the overall outcomes of the intervention.

The expected duration of participant involvement in the trial is approximately three years, contingent upon the individual's continued eligibility and adherence to the study protocol. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent, or non-compliance with study procedures. Participants will be closely monitored throughout the trial to ensure their safety and the integrity of the study data.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The data does not contain any information about the experimental medication's maximum daily dose, maximum total dose, or maximum treatment period. Furthermore, there is no information on whether the medication is a **paediatric formulation** or an **orphan drug**. The trial's main objective and full title are also not provided in the data.

No specific details regarding the assessment of efficacy in the clinical trial are provided in the available data. Information on parameters or endpoints, methods, schedule for measuring, collecting, and analyzing efficacy parameters, as well as tools or instruments involved in efficacy assessments, is not included. The estimated recruitment start date is December 1, 2023, and the estimated end date is February 14, 2027. The trial is categorized under phase 9, but further specifics on efficacy evaluation are not available.