Usnoflast for ALS
(UNITE-ALS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Usnoflast for individuals with Amyotrophic Lateral Sclerosis (ALS), a condition affecting nerve cells in the brain and spinal cord, leading to muscle weakness. Researchers aim to determine if Usnoflast can improve symptoms or slow ALS progression. The study includes groups receiving either 50 mg or 75 mg doses of Usnoflast or a placebo (inactive pill) to compare effects. Individuals who have experienced ALS symptoms, such as limb weakness or difficulty speaking or swallowing, for less than two years might be suitable for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the Usnoflast trial?
You may need to stop certain medications before joining the trial. If you're taking riluzole, sodium phenylbutyrate, taurursodiol, or edaravone, you can continue them if your dose is stable. However, you must stop medications that affect drug metabolism or absorption, like St. John's Wort, and certain other drugs at least 7 days or 5 half-lives before starting the trial.
Is there any evidence suggesting that Usnoflast is likely to be safe for humans?
Why do researchers think this study treatment might be promising for ALS?
Usnoflast is unique because it offers a new approach to treating ALS by using a specific active ingredient not found in current options. Most ALS treatments, like riluzole and edaravone, aim to slow disease progression or reduce oxidative stress. But Usnoflast works differently, potentially targeting other mechanisms involved in ALS. This fresh approach could provide new hope for slowing down the disease even further. Researchers are excited about its potential to address aspects of ALS that standard treatments might not fully cover.
What evidence suggests that Usnoflast might be an effective treatment for ALS?
Research has shown that Usnoflast may help slow the progression of ALS, a disease affecting nerve cells in the brain and spinal cord. In earlier studies, patients tolerated Usnoflast well, and it appeared to slow the loss of abilities. It also improved breathing, which is crucial for people with ALS. Although not all results reached statistical significance, patients taking the 75 mg dose, one of the treatment arms in this trial, achieved better scores on a test measuring ALS progression. These encouraging findings suggest Usnoflast could be a helpful treatment for ALS.12346
Who Is on the Research Team?
Deven V Parmar
Principal Investigator
Zydus Therapeutics Inc.
Are You a Good Fit for This Trial?
This trial is for people with ALS, who have had symptoms like weakness or shortness of breath for less than 2 years. They should be able to swallow pills and breathe well enough (60% capacity). If they're taking certain ALS meds, they need to be on a stable dose.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Usnoflast or placebo for 36 weeks to evaluate efficacy, safety, pharmacokinetics, and pharmacodynamics
Open-label extension
Participants receive Usnoflast (75 mg) for 16 weeks to confirm long-term safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Usnoflast
Trial Overview
The study tests Usnoflast at two doses (50 mg and 75 mg) against a placebo in patients with ALS. It aims to see if Usnoflast can help manage the disease better compared to not receiving any active medication.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
50 mg Usnoflast capsules and matching placebo of 25 mg capsule under fasting conditions twice a day orally for 36 weeks
25 mg + 50 mg Usnoflast capsules under fasting conditions twice a day orally for 36 weeks
Matching placebo of 25 mg and 50 mg under fasting conditions twice a day orally for 36 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zydus Therapeutics Inc.
Lead Sponsor
Citations
A phase 2, proof-of-concept, placebo-controlled, ...
Conclusion: Usnoflast 50 and 75 mg doses were well-tolerated in ALS patients, providing rationale for further studies of Usnoflast in ALS.
2.
alsnewstoday.com
alsnewstoday.com/news/usnoflast-well-tolerated-als-patients-shows-signs-efficacy-study/Usnoflast well tolerated in ALS patients and shows signs of...
The experimental ALS treatment usnoflast exhibited promising signs of slowed functional decline and improved breathing in a Phase 2 trial.
A phase 2, proof-of-concept, placebo-controlled ...
Though not significant (p > 0.05), compared with placebo, Usnoflast 75 mg demonstrated a difference of 2.78 (mITT) and 3.28 (per-protocol) in ALSFRS-R total ...
Zydus-Lifesciences-announces-completion-of-Phase-II(a)- ...
The improvement observed in SVC (Slow Vital. Capacity) in ALS patients has been encouraging in this 12-week trial. We now look forward to ...
FDA approves Zydus' trial of Usnoflast for ALS treatment
The trial's primary endpoint is the change in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score from baseline to week 36. Secondary ...
Zydus Lifesciences announces completion of Enrolment for ...
ALS is a rare, progressive and fatal neurodegenerative disease, with an average life expectancy of 3 to 5 years from the time of symptom onset.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.