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ACETYLCARNITINE HYDROCHLORIDE

Clinical trials are investigating ACETYLCARNITINE HYDROCHLORIDE in people with amyotrophic lateral sclerosis (ALS). These studies aim to measure whether it can help slow loss of function and improve self-sufficiency, while also looking at treatment effects in patient groups with this disease.

Table of Contents

Trial overview

The available clinical trial is studying ACETYLCARNITINE HYDROCHLORIDE in people with amyotrophic lateral sclerosis (ALS), a disease that affects nerve cells and muscle function.[1] The study is titled as a randomized phase II/III trial on the biological and clinical effects of acetyl-L-carnitine in ALS, and it is listed as authorised.[1]

This research is focused on whether the treatment can help with the progression of functional disability, which means loss of the ability to do everyday tasks.[1] The trial also looks at self-sufficiency, or how well a person can manage daily activities on their own.[1]

Who is being studied

The target population is people with amyotrophic lateral sclerosis.[1] The source data does not give more detailed rules for who can join, such as age, sex, or disease stage, so those details cannot be added here.[1]

The study plans to enroll 246 participants.[1] This number gives the researchers a group large enough to compare outcomes between treatment and placebo groups.[1]

Study design and phase

This is an interventional study, which means the researchers give a treatment and then measure the results.[1] It is described as randomized, so participants are assigned to groups by chance rather than by choice.[1]

The phase information in the source is listed as Phase 4, and the title also describes the trial as phase II/III.[1] This shows that the study is examining clinical effects in people and is not just an early test in the lab.[1]

What is being measured

The main outcome is the proportion of participants who remain self-sufficient after 48 weeks.[1] In this study, self-sufficiency is defined using ALSFRS-R items for swallowing, cutting food, handling utensils, and walking, and participants must score three or higher in all three items listed in the source description.[1]

The brief summary says the trial is assessing the effect of ACETYLCARNITINE HYDROCHLORIDE on progression of functional disability, measured by the ALSFRS-R scale.[1] The ALSFRS-R is a standard rating tool used in ALS research to track daily function over time.[1]

Treatment groups and doses

The study includes a placebo group and an active treatment group using Nicetile 500 mg polvere per soluzione orale, which is ACETYLCARNITINE HYDROCHLORIDE.[1] The summary also says that two dosages are being tested: 1.5 g/day and 3 g/day.[1]

A placebo is a comparison treatment that does not contain the active study drug.[1] Comparing the active treatment with placebo helps researchers see whether the study drug changes outcomes more than no active treatment.[1]

Patient-friendly terms

  • Functional disability means difficulty doing normal daily activities because of illness.[1]

  • Self-sufficiency means being able to manage important daily tasks without help.[1]

  • Swallowing, cutting food, handling utensils, and walking are everyday tasks used in the ALSFRS-R scale to measure function.[1]

  • Randomized means the study assigns people to groups by chance, which helps keep the comparison fair.[1]

  • Placebo means a non-active comparison treatment used in research studies.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06126315 Phase 4 Amyotrophic lateral sclerosis Authorised 246

FAQ

  • What is being studied in trials of ACETYLCARNITINE HYDROCHLORIDE? The trial is studying whether ACETYLCARNITINE HYDROCHLORIDE can affect the course of amyotrophic lateral sclerosis (ALS). It focuses on functional disability and whether people remain self-sufficient over time.
  • Who can take part in these trials? The trial is for people with amyotrophic lateral sclerosis. The source data does not list more detailed eligibility rules, such as age limits or disease stage.
  • What phase is the trial? This study is listed as Phase 4, and its title also describes it as a randomized phase II/III trial. That means it is testing the treatment in people and measuring clinical effects.
  • What result is the trial mainly measuring? The main result is the proportion of participants who remain self-sufficient after 48 weeks. Self-sufficiency is measured with parts of the ALSFRS-R scale, which checks swallowing, cutting food, handling utensils, and walking.
  • How many people are planned for the study? The trial plans to enroll 246 participants. This helps researchers compare the treatment and placebo groups more reliably.

Ongoing Clinical Trials on ACETYLCARNITINE HYDROCHLORIDE

  • Study on the Effects of Acetylcarnitine Hydrochloride in Patients with Amyotrophic Lateral Sclerosis (ALS)

    Recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Amyotrophic lateral sclerosis (ALS): A serious nerve disease that affects muscles and can cause weakness and loss of function over time.
  • Randomized: Participants are assigned to study groups by chance, not by choice. This helps make the comparison fair.
  • Placebo: A look-alike treatment with no active study drug. It is used to compare results with the real treatment.
  • Phase 4: A later stage of clinical research done in people, often to learn more about treatment effects in a larger group.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • Enrollment: The number of people planned to join a study.
  • ALSFRS-R: A rating scale used in ALS studies to measure daily function, such as swallowing, eating, and walking.
  • Self-sufficiency: Being able to do important daily tasks without help.
  • Functional disability: Loss of the ability to do normal daily activities because of disease.
  • Treatment arm: One of the groups in a clinical trial, such as the active treatment group or the placebo group.

References