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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Region Vaesterbotten Umea Sweden
Hospital Del Mar Barcelona Spain
Region Stockholm – SLSO Stockholm Sweden
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Universidade De Santiago De Compostela Santiago De Compostela Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Universitaire De Nice Nice France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Beaumont Hospital Dublin Ireland
Ddpltnlyg Kgcpnsbzend gcpzn Hanover Germany
Ctpsjd Cduadjm Nmwl Milan Italy
Ajkidlpfjh Pezoduoj Henmnfyf Dz Mfjhtuwod Marseille France
Cmphqf Hifepoolrnc Rcbfpufs Uahvtasipndzo Di Tqfpr Tours France
Arptxeg Osjwikvhzph Ulszvzgquhoax Ceartxmpzbye Dfwna Syyylw E Defay Szhqlvj Dc Tmyrtl Turin Italy
Istyl Ovxvmrpf Agarsahzkt Sfi Lduu Milan Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.05.2026
France France
Not yet recruiting
01.05.2026
Germany Germany
Recruiting
01.05.2026
Ireland Ireland
Not yet recruiting
01.05.2026
Italy Italy
Not yet recruiting
01.05.2026
Poland Poland
Recruiting
01.05.2026
Spain Spain
Recruiting
01.05.2026
Sweden Sweden
Recruiting
01.05.2026
The Netherlands The Netherlands
Recruiting
01.05.2026

Trial locations

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

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 ID:
2025-524002-16-00
Protocol code:
PL101-ALS301
Trial Phase:
Therapeutic confirmatory (Phase III)

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