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Blood test clues could speed up ALS drug development

NCT ID NCT07334743

Knowledge-focused Sponsor: Fondation Ophtalmologique Adolphe de Rothschild Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to find biological markers in the blood that can help measure whether a potential ALS therapy is working. Researchers will collect tiny particles shed by brain cells from 30 ALS patients and 30 healthy volunteers. By comparing these particles, they hope to identify signals that could be used in future early-stage trials of a treatment called ENGRAILED1.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could identify blood-based biomarkers that make it easier and faster to test a new ALS therapy in early-stage trials.
What could go wrong
This is an observational study, not a treatment trial. It is small (60 people) and exploratory, so the biomarkers found may not prove useful in later trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Study Population Description. Prospective cohort of 60 adults: 30 patients undergoing inpatient diagnostic work-up for suspected sporadic ALS at the HFAR neurology department and 30 age/sex-matched healthy controls.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For patients : Age ≥ 18 years. Diagnostic suspicion of amyotrophic lateral sclerosis (ALS). Planned inpatient admission in the HFAR neurology department for the standard diagnostic work-up as part of routine care: clinical evaluation, neuropsychological assessment, nerve conduction studies/EMG, motor evoked potentials (TMS/MEP), brain and spinal MRI, pulmonary function testing, lumbar puncture, and standard blood tests. Explicit written informed consent to participate in the study. Affiliation with or beneficiary of a social security system. Non-inclusion criteria: Patient under legal protection/guardianship. Pregnant or breastfeeding woman. Active infection within the 4 weeks preceding biological sampling. Ongoing diagnosis and management of cancer. Secondary exclusion criterion: ALS diagnosis not confirmed. For Healthy Controls : Age ≥ 18 years. Explicit written informed consent to participate in the study. Affiliation with or beneficiary of a social security system. Exclusion Criteria: * Patient under legal protection/guardianship. * Pregnant or breastfeeding woman. * Diagnosed neurological disease. * Self-reported cognitive impairment. * Active infection within the 4 weeks prior to biological sampling. * Current diagnosis and management of cancer.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis ENGRAILED1

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hopital Fondation Adolphe de Rothschild

    RECRUITING

    Paris, 75019, France

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