Not recruitingRare disease

Study on the Effects of NX210c and Glucose in Adults 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 will test a treatment known as NX210c, which is a type of synthetic protein designed to be given through an injection into the veins. The purpose of the study is to evaluate how effective and safe this treatment is for people with ALS.

Participants in the study will receive multiple doses of NX210c over a period of time, and some may receive a placebo instead. The study will monitor the effects of the treatment on certain markers in the blood and spinal fluid, which can provide information about the disease's progression and the treatment's impact. The study will also assess how well participants tolerate the treatment and any side effects they may experience.

Throughout the study, participants will have regular check-ups and tests to track their health and the treatment's effects. The study aims to gather important information that could help in understanding and potentially improving the treatment of Amyotrophic Lateral Sclerosis in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's objectives and procedures. The patient must provide informed consent to participate.
The patient will undergo initial assessments to confirm eligibility, including a review of medical history and a physical examination.
Step 2
Baseline assessments
Baseline assessments will be conducted to gather initial data. This includes blood tests to measure neurofilament light chain (NfL) levels and other biomarkers.
A lumbar puncture may be performed to collect cerebrospinal fluid (CSF) for further analysis.
Step 3
Treatment administration
The patient will receive multiple intravenous infusions of NX210c or a placebo. The exact schedule and dosage will be determined by the study protocol.
In addition to NX210c, the patient may receive a glucose solution as part of the infusion process.
Step 4
Follow-up assessments
Follow-up assessments will occur at specified intervals to monitor the patient's response to the treatment.
These assessments will include blood tests, CSF analysis, and evaluations of physical and neurological health.
Step 5
End of treatment
At the end of the treatment period, final assessments will be conducted to evaluate the overall effects of the treatment.
The patient will be monitored for any changes in health status and any potential side effects.
Step 6
Long-term follow-up
The patient will continue to be monitored for a period after the treatment ends to assess long-term effects and safety.
This may include additional visits and tests as outlined in the study protocol.

Who can join the trial?

16 criteria

The patient must be able to give their agreement to participate and be able to travel to the study location. They should also be willing to follow all study rules, including having two procedures to collect fluid from the lower back (lumbar punctures).
The patient must have good veins for drawing blood, as no central line (a tube placed in a large vein) will be allowed.
The patient must have enough cerebrospinal fluid (CSF) during the initial check-up, with at least 1.5 mL available.
The patient's body weight must be 110 kg or less at the start of the study.
Female patients must not be pregnant and must have a negative pregnancy test at the start and during the study.
Female patients must not be breastfeeding, should not plan to become pregnant during the study, and must use reliable birth control methods or avoid sexual intercourse. Women who can become pregnant must use two forms of birth control, one being a male condom, during the study and for 90 days after the last treatment. Women who cannot become pregnant include those who are sterilized or have gone through menopause.
Male patients must either not engage in sexual activity or use effective birth control. If having intercourse with women who can become pregnant, both partners must use two forms of birth control, one being a male condom, during the study and for 90 days after the last treatment. Men who have had a vasectomy must have no sperm or agree to use birth control or abstain from intercourse.
Male patients must not donate sperm from the start of the study until 90 days after the last treatment.
Participants must be 18 years or older when agreeing to join the study.
Patients must have a diagnosis of Amyotrophic Lateral Sclerosis (ALS), which can be possible, probable, or definite, based on specific criteria.
The duration of the disease must be 36 months or less from the first symptoms to the start of the study.
The patient's ALS stage must be 3 or less at the start of the study, according to a specific staging system.
The patient's blood test results for a specific protein (NfL) must match the ALS diagnosis before the initial check-up.
The patient must have a blood test result for the NfL protein at the start of the study.
The patient must have a breathing test result (SVC) of 55% or more, adjusted for gender, height, and age, at the start of the study.
Patients taking riluzole or other ALS treatments must have been on a stable dose for at least 30 days before the study starts. Patients who have never taken riluzole or stopped it at least two weeks before the initial check-up can join the study.

Who cannot join the trial?

5 criteria

Patients who have a medical condition other than 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 by the study, but it is not specified here.
Patients who are not part of the specified clinical trial group cannot participate. This group is usually defined by the study, but it is not specified here.
Both male and female patients are considered for participation, so exclusion is not based on gender.
Patients who are part of a vulnerable population may be excluded. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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

CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
CHU Gabriel-Montpied
Verified
Clermont Ferrand, France
Centre Hospitalier Et Universitaire De Limoges
Verified
Limoges, France

Trial locations

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Investigated drugs

NX210c is an investigational medication being studied for its potential effects in patients with amyotrophic lateral sclerosis (ALS). The trial aims to evaluate how this medication impacts certain biomarkers in the blood and cerebrospinal fluid, which may be related to the integrity of the blood-brain barrier. The study involves multiple intravenous infusions of NX210c to assess its efficacy, safety, and tolerability in participants.

What is already known about the treatment

NX210c – This medication is administered through multiple intravenous infusions. It is currently being studied in a phase II clinical trial for its potential use in treating Amyotrophic Lateral Sclerosis (ALS). The main therapeutic indication is to assess its effect on blood neurofilament light chain (NfL) levels and biomarkers of blood-brain barrier integrity. NX210c works at the molecular level by potentially influencing these biomarkers, which are associated with nerve damage and disease progression in ALS. It falls under the pharmacological classification of investigational drugs, as it is still undergoing clinical evaluation.

Investigated diseases

Amyotrophic Lateral Sclerosis (ALS) – ALS is a progressive neurological 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, twitching, and an eventual loss of muscle function. 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 disability.