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Study on the Effects of ILB and Riluzole for Patients with Amyotrophic Lateral Sclerosis (ALS)

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What is this trial about?

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

This clinical trial is focused on studying a disease called Amyotrophic Lateral Sclerosis (ALS), which is a condition that affects the nerve cells in the brain and spinal cord, leading to muscle weakness and loss of muscle control. The study is comparing two treatments: a new drug called ILB and an existing medication known as Riluzole. ILB is given as a solution for injection, while Riluzole is taken as film-coated tablets. The purpose of the study is to evaluate how effective ILB is compared to Riluzole in slowing down the progression of ALS.

Participants in the study will be randomly assigned to receive either ILB or Riluzole, and some may receive a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are not biased. The study will last for a period of 48 weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment. These check-ups will include various tests and assessments to track changes in the participants' condition.

The study aims to gather information on the safety and effectiveness of ILB, as well as its impact on certain biological markers related to ALS. By comparing the results from the ILB group with those from the Riluzole group, researchers hope to determine if ILB can offer a new and effective treatment option for people living with ALS. The study will also collect data on any side effects experienced by participants to ensure the safety of the treatments being tested.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, the participant will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the investigational medication or the standard treatment.
Step 2
Medication administration
Participants in the study will receive either the investigational medication ILB or a placebo, which is a substance with no active medication. The ILB is administered as a subcutaneous injection, which means it is injected under the skin. The frequency and dosage will be determined by the study protocol.
Participants will also receive either Rilutek (riluzole) or a placebo in the form of film-coated tablets taken orally. The standard dosage for Rilutek is 50 mg, taken twice daily.
Step 3
Monitoring and assessments
Throughout the trial, participants will undergo regular assessments to monitor their health and the effects of the medication. These assessments may include physical examinations, laboratory tests, and cardiac monitoring.
Participants will also be evaluated using the Amyotrophic Lateral Sclerosis Functional Rating Scale (revised) (ALSFRS-R) to measure changes in their condition over time.
Step 4
Follow-up visits
Participants will have scheduled follow-up visits at specific intervals, such as every few weeks, to assess their progress and any side effects they may experience.
During these visits, additional tests may be conducted, including blood tests and other evaluations to measure biomarkers and other health indicators.
Step 5
End of the trial
The trial will conclude after a predetermined period, such as 24 or 48 weeks, depending on the study design.
At the end of the trial, participants will undergo a final assessment to evaluate the overall effects of the treatment and any changes in their condition.

Who can join the trial?

8 criteria

Age between 18 and 80 years old at the time of signing the consent form.
Must be in a stable health condition based on a medical check-up, which includes reviewing your medical history, a physical exam, lab tests, and heart monitoring.
Must be a male or female diagnosed with Amyotrophic Lateral Sclerosis (ALS) according to specific medical guidelines.
ALS symptoms must have started 24 months or less before the screening visit.
The rate of disease progression must be at least 0.4, as measured by a specific scale at screening.
Forced Vital Capacity (FVC), which measures lung function, must be at least 60% of what is expected for your gender, height, and age.
Must have started treatment with Riluzole (100 mg per day) at least 2 weeks before screening and be willing to stop taking it 48 hours before the first day of the study.
Must have a score of at least 28 points on the ALS Functional Rating Scale-Revised (ALSFRS-R), which measures the impact of ALS on daily activities, at screening.

Who cannot join the trial?

3 criteria

Patients who do not have Amyotrophic Lateral Sclerosis (ALS) cannot participate. ALS is a disease that affects the nerve cells in the brain and spinal cord.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Sykehuset I Vestfold HF
Responsive
Tonsberg, Norway
Sykehuset Oestfold HF Kalnes
Responsive
Graalum, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

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Investigated drugs

ILB®
is a medication being tested to see if it can help slow down the progression of amyotrophic lateral sclerosis (ALS), a disease that affects the nerve cells in the brain and spinal cord. The goal of using ILB® in this study is to find out if it can effectively reduce the symptoms and progression of ALS, making it easier for patients to manage their condition.
Riluzole
is a medication that is already used to treat amyotrophic lateral sclerosis (ALS). It works by helping to protect nerve cells from damage, which may slow down the progression of the disease. In this study, Riluzole is being used as a comparison to see how well ILB® performs in reducing the symptoms and progression of ALS.

Riluzole

What is already known about the treatment

ILB®
ILB® is administered in a form that is suitable for patients with Amyotrophic Lateral Sclerosis (ALS), although the specific method of application is not detailed here. It is currently being studied in clinical trials to assess its effectiveness and safety compared to Riluzole, a standard treatment for ALS. The main therapeutic indication for ILB® is to slow down the progression of ALS, a condition that affects nerve cells in the brain and spinal cord. At the molecular level, ILB® is believed to work by protecting nerve cells from damage, although the exact mechanism is still under investigation. It falls under the pharmacological classification of neuroprotective agents.
Riluzole
Riluzole is typically administered orally in tablet form and is a well-established medication in the treatment of Amyotrophic Lateral Sclerosis (ALS). It is widely recognized in medical literature as the first drug approved to slow the progression of ALS. The main therapeutic indication for Riluzole is to extend survival and delay the need for ventilatory support in ALS patients. At the molecular level, Riluzole works by reducing the release of glutamate, a neurotransmitter that can be harmful in excessive amounts, thereby protecting nerve cells. It is classified pharmacologically as a glutamate release inhibitor.

Investigated diseases

Amyotrophic Lateral Sclerosis – Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. It leads to the gradual degeneration and death of motor neurons, which are responsible for controlling voluntary muscles. As these neurons deteriorate, the brain loses the ability to initiate and control muscle movement. This results in muscle weakness and atrophy, often starting in the limbs and spreading to other parts of the body. Over time, individuals with ALS may experience difficulty speaking, swallowing, and breathing. The progression of the disease varies among individuals, but it typically leads to increasing physical disability.