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Scientists hunt for biological clues to how ALS drug affects the body

NCT ID NCT04259255

Knowledge-focused Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study follows about 74 adults with ALS who have already decided to take the drug Edaravone (Radicava). Researchers collect blood and urine samples over 24 weeks to measure various biomarkers—molecules that might show how the drug affects oxidative stress, inflammation, and nerve damage. The goal is to find measurable biological signs that could help track the drug's effects in future research.

What this could mean

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

Active substance
Edaravone (Radicava)
What this could lead to
If successful, this study could identify biological markers that help measure how Edaravone works in ALS, potentially guiding future treatment monitoring.
What could go wrong
This is an observational study focused on biomarkers, not on proving the drug works. It may not lead to new treatments or change current care.

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

74 people

The number who actually took part.

Started

Oct 2019

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

This study will be conducted in participants who have sporadic or familial amyotrophic lateral sclerosis (ALS) as defined by revised El Escorial criteria. Participants must provide written informed consent prior to screening. At screening, eligible patient must be at least 18 years old with a decision made to prescribe Edaravone prior to consenting. Participants who are either Edaravone naïve or who did not receive any Edaravone dose within one month of consenting are eligible for inclusion given they meet all other protocol requirements.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Male and female aged 18 years or older at enrollment * Sporadic or familial ALS diagnosed as possible, probable, probable-laboratory supported or definite as defined by the World Federation of Neurology revised El Escorial criteria * Decision made to prescribe Edaravone prior to screening * Participant will likely be able to obtain commercial Edaravone and likely to complete 6 cycles of treatment, per site investigator estimation * Participant either naïve to Edaravone or who did not receive any Edaravone does within 1 month prior to screening * Signed informed consent by the subject, or a witness if a subject cannot read or write or is physically unable to talk or write, obtained before any study-related activities are undertaken Exclusion Criteria: * Participant with a contraindication to Edaravone * Participant is participating in an interventional clinical trial

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis motor neuron disorder

As listed by the trial registrant

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

ALS Amyotrophic lateral sclerosis

Contacts and locations

Locations

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Jefferson Weinberg ALS Center

    Philadelphia, Pennsylvania, 19107, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Las Vegas Clinic

    Las Vegas, Nevada, 89145, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02214, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Mercy Health

    Grand Rapids, Michigan, 49503, United States

  • Neurology Associates, P.C.

    Lincoln, Nebraska, 68506, United States

  • OhioHealth

    Columbus, Ohio, 43215, United States

  • SunnyBrook Research Institute

    Toronto, Ontario, M4N 3M5, Canada

  • Temple University Lewis Katz School of Medicine

    Philadelphia, Pennsylvania, 19140, United States

  • UC Davis Health

    Sacramento, California, 95817, United States

  • UCLA Als Clinic

    Los Angeles, California, 90024, United States

  • University of California, San Francisco

    San Francisco, California, 94417, United States

  • University of Colorado

    Denver, Colorado, 80309, United States

  • University of Florida, Jacksonville -Neurology Research Department

    Jacksonville, Florida, 32209, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

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