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Study of Lithium Treatment for Patients with Amyotrophic Lateral Sclerosis (ALS) to Evaluate Survival Rate

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What is this trial about?

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

This clinical trial focuses on studying patients with Amyotrophic Lateral Sclerosis (ALS), a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. The study will evaluate the effectiveness of lithium treatment compared to placebo in people with ALS.

The main purpose of this research is to determine if lithium can improve survival rates in ALS patients. The study will specifically look at how long patients survive without developing respiratory problems severe enough to require breathing support. The treatment involves taking lithium capsules by mouth, with doses up to 1200 milligrams per day over a period of 24 months.

During the study, participants will be monitored for changes in their daily functioning, breathing ability, quality of life, and thinking skills. The research team will also track any changes in laboratory measurements and watch for possible side effects. Patients who are already taking riluzole, a common ALS medication, may continue using it if they have been on a stable dose.

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

    Initial qualification

    You must be 18 years or older and have a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS)

    Your TRICALS risk profile must be between -6.00 and -2.00

    If you are taking riluzole, you need to be on a stable dose for at least 30 days before starting the study, or have stopped taking it at least 30 days before

  2. Step 2

    Medical requirements

    Women who can become pregnant must have a negative pregnancy test and not be breastfeeding

    Both men and women must use effective birth control methods during the study

    Men must continue birth control for 3 months after the last dose of study medication

    Men should not plan to father a child or donate sperm during the study and for 3 months after

  3. Step 3

    Treatment period

    You will receive either lithium or placebo (inactive capsules) to take by mouth

    The placebo capsules contain lactose and polyvinylpyrrolidone

    The study will continue until October 30, 2026

  4. Step 4

    Monitoring during study

    Your daily functioning will be measured using the ALSFRS-R score

    Your breathing function will be tested using SVC (breathing capacity test)

    Your quality of life will be evaluated using questionnaires

    Regular laboratory tests will be performed

    Your neurological condition will be monitored

    Any side effects will be recorded and evaluated

Who can join the trial?

13 criteria

  • Must be at least 18 years old at screening
  • Must have a confirmed diagnosis of ALS (Amyotrophic Lateral Sclerosis) according to specific medical criteria
  • Must be able to provide informed consent and follow study procedures
  • Must have a specific TRICALS risk profile score between -6.00 and -2.00 (a medical assessment score used to evaluate ALS progression)
  • If taking riluzole (a medication for ALS), must be on a stable dose for at least 30 days before starting the study, or have stopped taking it at least 30 days before
  • Women who can become pregnant must:
    • Have a negative pregnancy test at the start of the study
    • Not be breastfeeding
    • Use effective birth control throughout the study
    • Men must:
      • Use contraception during the study and for 3 months after
      • Not plan to father a child during the study and for 3 months after
      • Not donate sperm during the study and for 3 months after
      • Women must either:
        • Be unable to become pregnant (post-menopausal or surgically sterile)
        • Use effective birth control methods (such as hormonal contraception or intrauterine device)

Who cannot join the trial?

15 criteria

  • Age below 18 or above 80 years old
  • Pregnant or breastfeeding women
  • History of other serious neurological conditions besides ALS (Amyotrophic Lateral Sclerosis)
  • Severe respiratory problems requiring permanent ventilation
  • Current participation in other clinical trials
  • Inability to provide informed consent
  • Severe liver or kidney disease
  • History of allergic reactions to similar medications
  • Major surgery within the last 3 months
  • Significant heart problems or uncontrolled high blood pressure
  • Active infections requiring treatment
  • Mental health conditions that could interfere with the study
  • Alcohol or drug abuse within the past year
  • Use of medications that could interact with the study drug
  • Life expectancy less than 6 months due to other medical conditions
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Investigated drugs

Based on the provided data, I cannot extract specific medications or therapies as the source information does not contain details about the treatments used in the trial. While the trial title indicates it's a multi-arm study for evaluating drug efficacy in ALS patients, the specific medications are not listed in the provided data. The trial appears to be comparing multiple drugs against placebo for survival outcomes in ALS patients, but without the actual medication names being specified, I cannot provide descriptions of the treatments involved.

What is already known about the treatment

Since no specific medication names are provided in the source data, I cannot create medication descriptions. The trial data only shows that this is a study for ALS (Amyotrophic Lateral Sclerosis) treatments, but doesn't specify which medications are being tested. To create accurate medication descriptions, I would need information about the specific drugs being evaluated in this clinical trial. If you can provide the names of the medications being tested in this "Magnet Study," I will be happy to create descriptions following the requested format.

Investigated diseases

Amyotrophic Lateral Sclerosis (ALS) - A progressive neurological disease that affects nerve cells responsible for controlling voluntary muscle movement. The disease causes the death of motor neurons, which leads to the brain losing its ability to initiate and control muscle movement. Over time, patients experience gradual weakening of muscles used for activities like walking, speaking, swallowing, and breathing. The condition typically begins with muscle twitching, weakness in a limb, or slurred speech. As motor neurons continue to die, the muscles progressively weaken and begin to atrophy. The disease affects different people in different ways, with varying patterns of progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516559-41-00Protocol codeMagnet LithiumEstimated enrolment171 patientsSponsorStichting TRICALS Foundation

sourced from the EU Clinical Trials Register and site verification

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