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A study to evaluate the effectiveness and safety of pridopidine hydrochloride in patients with amyotrophic lateral sclerosis

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What is this trial about?

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

This study focuses on Amyotrophic Lateral Sclerosis, a rare disease that affects the nerve cells in the brain and spinal cord. This condition can lead to difficulties with muscle control, movement, and speech. The purpose of the study is to evaluate how the drug pridopidine affects the progression of this disease.

Participants in the study will be given either pridopidine in a capsule form or a placebo. The study uses a double-blind method, which means that neither the participants nor the researchers know who is receiving the active medication or the placebo during the course of the trial. This is done to ensure the results are as accurate as possible.

During the trial, participants will be monitored over a period of time to observe changes in their physical abilities and overall health. This includes tracking how well they can speak and their ability to breathe effectively. The study also monitors any side effects or changes in health to ensure safety throughout the process.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    You will receive either pridopidine or a placebo, which is an inactive substance used for comparison.

    The pridopidine is provided in a 90 mg hard capsule and is taken by mouth.

    The duration of the medication period is up to 48 weeks.

  2. Step 2

    <b>evaluation of disease progression</b>

    The ALSFRS-R, a scale used to measure physical function, is assessed at week 26 and week 48.

    The bulbar subdomain, which refers to functions related to speech and swallowing, is monitored through week 48.

    The ALSAQ-40, a questionnaire regarding quality of life, is evaluated through week 48.

  3. Step 3

    <b>speech and breathing assessments</b>

    The speaking rate and the intelligibility of speech, which is how clearly words are understood, are measured at week 26 and week 48.

    The slow vital capacity, a measure of the amount of air that can be breathed out slowly, is monitored through week 48.

  4. Step 4

    <b>safety and survival monitoring</b>

    adverse events, which are unexpected medical side effects, are recorded throughout the study.

    vital signs, laboratory tests, and ECG (an electrical recording of the heart's activity) are monitored for changes.

    The C-SSRS, a tool used to monitor mood and suicidal thoughts, is tracked during the study.

    overall survival is tracked through week 96.

Who can join the trial?

5 criteria

  • You must be between 18 and 80 years old at the time you agree to join the study.
  • You must have a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS), which is a condition that affects the nerve cells in the brain and spinal cord, using specific medical guidelines known as El Escorial criteria.
  • Your symptoms (the physical signs of the disease) must have started 18 months ago or less at the time of your first screening.
  • Your Forced Vital Capacity (FVC), which is a measurement of how much air your lungs can hold, must be at least 60% of what is expected for a healthy person of your age and size.
  • Your score on a specific tool used to predict how the disease might progress, called the TRICALS Risk Profile Calculator, must fall between -6 and -2.

Who cannot join the trial?

5 criteria

  • Having a tracheostomy, which is a tube placed in your neck to help you breathe, or needing a machine to help you breathe all the time.
  • Having important heart disease, a history of arrhythmia (irregular heartbeats), or a type of irregular heartbeat called atrial fibrillation that is not controlled by medicine.
  • Having a heart rhythm issue called ventricular tachycardia that causes symptoms or is not controlled, or having a specific type of electrical blockage in the heart known as left bundle branch block.
  • Having mental health conditions, cognitive impairment (problems with thinking or memory), dementia (a decline in mental ability), or issues with substance abuse that would make it difficult to understand the study or give permission to join.
  • Having any other serious or changing medical problems, besides ALS, that could put your safety at risk or make it difficult to finish the study.
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Investigated drugs

Pridopidine is a medication being tested to see if it can help slow down the progression of amyotrophic lateral sclerosis (ALS) in patients.

What is already known about the treatment

  • Pridopidine

    This medication is taken by mouth in the form of a hard capsule. Currently being studied in late-stage clinical trials, it is being investigated for its potential to help people with Amyotrophic Lateral Sclerosis, a rare disease that affects nerve cells. It works by increasing the activity of certain proteins in the brain that help protect nerve cells and maintain their health. This drug is classified as a selective sigma-1 receptor agonist, meaning it targets specific molecules to help stabilize nerve cell functions.

  • Pridopidine placebo

    This is an inactive substance administered in the same way as the study medication but contains no active medicine. It is used in clinical trials as a comparison tool to help researchers determine if the real medication actually produces a meaningful effect. Because it has no medicinal properties, it does not interact with the body at a molecular level or treat any specific medical condition.

Investigated diseases

Amyotrophic Lateral Sclerosis - This is a condition that affects the nerve cells responsible for controlling voluntary muscles. Over time, these nerve cells gradually weaken and die. As the disease progresses, muscles become increasingly weak and may eventually stop working altogether. This can affect a person's ability to speak, swallow, and breathe. The loss of muscle control typically spreads throughout the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524002-16-00Protocol codePL101-ALS301Estimated enrolment500 patientsSponsorFerrer Internacional S.A.

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