In short
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.
Key points
- Clinical trials are studying USNOFLAST in people with amyotrophic lateral sclerosis (ALS). The main trial listed is a phase 2 interventional study with 244 planned participants. It compares USNOFLAST with placebo and looks at disease progression, ALSFRS-R total score, and survival over 36 weeks. The study is authorised and uses an oral form of the treatment. This trial is focused on whether USNOFLAST may help people with ALS.
Trial overview
The main clinical trial listed for USNOFLAST is NCT07023835, titled Usnoflast Neuromuscular Investigation for Treatment Efficacy in ALS (UNITE-ALS). It is an interventional study, which means researchers give a study treatment and then measure the results. The study is in Phase 2 and is currently Authorised.
Who is being studied
This trial is studying people with amyotrophic lateral sclerosis (ALS). 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. Based on the source, the key target group is adults living with ALS who may take part in a study of USNOFLAST.
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.
The primary outcome is change in disease progression from baseline through 36 weeks, measured by the ALSFRS-R total score and survival. 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. Survival is also being tracked because it shows how long participants live during the study period.
Trial design and treatment groups
The study compares USNOFLAST with placebo. 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. The source also says the placebo will be identical to USNOFLAST capsules in size, shape, and color.
Trial status and size
The listed trial is Authorised, so it has approval to run. The planned enrollment is 244 participants.
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. In this case, the patient group is people with ALS.
Key patient terms
Primary outcome means the main result the researchers are watching most closely. In this study, that is disease progression, ALSFRS-R total score, and survival over 36 weeks.
Phase 2 means the study is past the first safety-only stage and is now looking more closely at whether the treatment may work. Interventional means the researchers are actively giving a treatment instead of only observing people.
Placebo helps researchers understand whether any changes are due to USNOFLAST rather than chance or expectation. This is important when studying a disease like ALS, where function can change over time.