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USNOFLAST

Clinical trials are investigating USNOFLAST in people with amyotrophic lateral sclerosis (ALS). These studies aim to see whether USNOFLAST is safe and effective, and how it affects disease progression and survival. The main trial listed here is a phase 2 study in adults with ALS.

Table of Contents

Trial overview

The main clinical trial listed for USNOFLAST is NCT07023835, titled Usnoflast Neuromuscular Investigation for Treatment Efficacy in ALS (UNITE-ALS).[1] It is an interventional study, which means researchers give a study treatment and then measure the results.[1] The study is in Phase 2 and is currently Authorised.[1]

Who is being studied

This trial is studying people with amyotrophic lateral sclerosis (ALS).[1] ALS is a disease that affects nerve cells and leads to muscle weakness over time.

The trial data provided here do not list extra details about age limits, disease stage, or other entry rules.[1] Based on the source, the key target group is adults living with ALS who may take part in a study of USNOFLAST.[1]

What the trial measures

The main goal is to evaluate the efficacy of USNOFLAST versus placebo, meaning the researchers want to see whether the study treatment helps more than the inactive comparison treatment.[1]

The primary outcome is change in disease progression from baseline through 36 weeks, measured by the ALSFRS-R total score and survival.[1] Baseline means the starting point before treatment begins.

ALSFRS-R is a rating scale used to track how ALS affects daily function, such as movement and breathing.[1] Survival is also being tracked because it shows how long participants live during the study period.[1]

Trial design and treatment groups

The study compares USNOFLAST with placebo.[1] A placebo is made to look like the study drug but does not contain the active treatment, so the results can be compared fairly.

The intervention is given by oral use, which means by mouth.[1] The source also says the placebo will be identical to USNOFLAST capsules in size, shape, and color.[1]

Trial status and size

The listed trial is Authorised, so it has approval to run.[1] The planned enrollment is 244 participants.[1]

This is a moderate-size phase 2 study, which is often used to learn more about whether a treatment may help a specific patient group.[1] In this case, the patient group is people with ALS.[1]

Key patient terms

Primary outcome means the main result the researchers are watching most closely.[1] In this study, that is disease progression, ALSFRS-R total score, and survival over 36 weeks.[1]

Phase 2 means the study is past the first safety-only stage and is now looking more closely at whether the treatment may work.[1] Interventional means the researchers are actively giving a treatment instead of only observing people.[1]

Placebo helps researchers understand whether any changes are due to USNOFLAST rather than chance or expectation.[1] This is important when studying a disease like ALS, where function can change over time.[1]

Trial ID Phase Condition Studied Status Enrollment
NCT07023835 Phase 2 Amyotrophic Lateral Sclerosis (ALS) Authorised 244

FAQ

  • What is being studied in the USNOFLAST trials? The trial is studying whether USNOFLAST can help slow ALS progression compared with placebo. The main results are measured with a standard ALS score and survival.
  • Who can take part in the trial? The listed study is for people with amyotrophic lateral sclerosis (ALS). The trial data do not give more detailed participation rules here.
  • What phase is the USNOFLAST trial? The trial is a phase 2 study. Phase 2 trials usually look more closely at whether a treatment works and continue to monitor safety.
  • What outcomes are the researchers measuring? The main outcomes are change in disease progression over 36 weeks, ALSFRS-R total score, and survival. ALSFRS-R is a rating scale used to track function in ALS.
  • Is the trial using a comparison group? Yes. USNOFLAST is being compared with placebo. A placebo looks like the study drug but does not contain the active treatment.

Ongoing Clinical Trials on USNOFLAST

  • A study to evaluate the effectiveness and safety of Usnoflast in adults with Amyotrophic Lateral Sclerosis (ALS)

    Not yet recruiting

    2 1
    Investigated drugs:
    Belgium France Germany Ireland Italy The Netherlands +3

Glossary

  • Amyotrophic Lateral Sclerosis (ALS): A serious nerve disease that slowly weakens muscles and affects movement, speaking, swallowing, and breathing.
  • Placebo: An inactive treatment that looks like the study drug. It helps researchers compare results fairly.
  • Phase 2: A mid-stage clinical trial that looks at whether a treatment may work and continues to watch safety.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • ALSFRS-R total score: A score used to measure how well a person with ALS can do everyday tasks such as speaking, walking, and breathing.
  • Disease progression: How fast a disease gets worse over time.
  • Survival: How long people remain alive during a study period.
  • Enrollment: The number of people planned to join a trial.
  • Authorized: The trial has been approved to start.
  • Oral use: Taken by mouth.

References