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Tests treatment safety and results for Amyotrophic Lateral Sclerosis (ALS)
Official title Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT07023835
What this study is testing
What is 50 mg Usnoflast?
50 mg Usnoflast is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for amyotrophic lateral sclerosis (als).
Also referred to as Not any.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of probable or definite Amyotrophic lateral sclerosis, according to the revised version of the El Escorial World Federation of Neurology...
- Time since onset of first symptom of Amyotrophic lateral sclerosis ≤24 months. Date of Amyotrophic lateral sclerosis symptom onset. For the purposes...
- Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised score of ≥35 at screening.
- Slow vital capacity: ≥60% of predicted capacity at the screening visit.
- Be able to swallow capsules.
You likely can't join if
- Presence of unstable psychiatric disease, cognitive impairment, dementia, or substance abuse that would impair the ability of the subject to provide...
- Serious illness (e.g., pneumonia, septicemia) within 4 weeks of the screening visit; infection requiring hospitalization or treatment with...
- Active herpes zoster infection within 2 months prior to the screening visit.
- Any medical condition that promotes suicidal attempt or behavior within 6 months prior to the screening visit and in the opinion of the investigator...
- History of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or active cancer or another medically significant illness...
- Known allergy, sensitivity, or intolerance to Investigational product or excipients.
See the full eligibility criteria
Who can join
- Diagnosis of probable or definite Amyotrophic lateral sclerosis, according to the revised version of the El Escorial World Federation of Neurology criteria
- Time since onset of first symptom of Amyotrophic lateral sclerosis ≤24 months. Date of Amyotrophic lateral sclerosis symptom onset. For the purposes of this study, the date of symptom onset will be defined as the date...
- Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised score of ≥35 at screening.
- Slow vital capacity: ≥60% of predicted capacity at the screening visit.
- Be able to swallow capsules.
- Either not currently receiving riluzole/sodium phenylbutyrate and taurursodiol/tofersen or on a stable dose of riluzole/sodium phenylbutyrate and taurursodiol/tofersen for at least 4 weeks before the screening visit...
- Either not currently receiving edaravone or on edaravone treatment. people receiving edaravone must have completed at least 1 cycle of treatment before the screening visit and are expected to continue with a stable dose...
- Capable of providing informed consent and complying with study procedures in the opinion of the investigator
What rules you out
- Presence of unstable psychiatric disease, cognitive impairment, dementia, or substance abuse that would impair the ability of the subject to provide informed consent, in the opinion of the investigator.
- Serious illness (e.g., pneumonia, septicemia) within 4 weeks of the screening visit; infection requiring hospitalization or treatment with intravenous antibiotics, antivirals, or antifungals within 4 weeks of screening...
- Active herpes zoster infection within 2 months prior to the screening visit.
- Any medical condition that promotes suicidal attempt or behavior within 6 months prior to the screening visit and in the opinion of the investigator might interfere with subject's participation in the study or is a risk...
- History of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or active cancer or another medically significant illness other than Amyotrophic lateral sclerosis, precluding safe participation...
- Known allergy, sensitivity, or intolerance to Investigational product or excipients.
- people who have taken concomitant medications that are substrates of drug metaboliz-ing enzymes (Cytochrome P450 1A2 and/or Cytochrome P450 2B6) within 7 days or 5 half-lives of the medication (whichever is longer)...
- Use of any steroids, colchicine, or anti-IL-1 inhibitors within 7 days or 5 half-lives of the medication (whichever is longer) prior to the first dose of Investigational product administration.
- Use of any investigational drug concurrently or within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of Investigational product administration.
- Any clinically significant condition and/or laboratory significant value that would prevent the subject from participating in the study in the opinion of the investigator.
- Received a live vaccine within 14 days before the screening visit or planning to receive during the study duration.
- people who have received stem cell or gene therapy for Amyotrophic lateral sclerosis at any time in the past.
- Following laboratory test values at screening:
- Alanine aminotransferase or Aspartate aminotransferase values \>3.0 × Upper Limit of Normal
- Bilirubin \>1.5 × Upper Limit of Normal unless the subject has documented Gilbert's syndrome (isolated bilirubin \>1.5 × Upper Limit of Normal is acceptable if bilirubin is fractionated, and direct bilirubin is \<35%)
- Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2
- For those participating in the optional Cerebrospinal fluid collection, contraindications to lumbar puncture including but not limited to lumbar scoliosis, coagulopathy, infection at site of puncture, or use of...
- people with history of epilepsy within 6 months of screening visit.
- Surgery within last 3 months or planned major surgery within next 3 months from the date of screening (other than minor cosmetic surgery and minor dental surgery).
- Use or intended use of any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 4 weeks of screening and up to end of study. Use of such medication...
- Receiving an elemental diet or parenteral nutrition.
- Received blood transfusion within 3 months prior to screening.
- people with Human immunodeficiency virus, hepatitis B, hepatitis C, coronary artery disease, or active gastrointestinal condition that might interfere with drug absorption.
- Inability to be venipunctured or those not able to tolerate venous puncture.
- Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of employees of investigator...
- Any condition not mentioned in any of above criteria that, as per the investigator, would hinder participation of the subject in the study. This may include, but not limited to, considerations of safety, compliance, or...
- If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception during the study and for at least 1 month after...
- Completion in the assigned by chance, double blind Usnoflast study (main study).
- people who elect to continue treatment after completion of Usnoflast phase 2b study must enrol in the OLE within 28 days of the completion of Week 36 visit of the main study.
- Provide a new informed consent to enter the OLE phase. Exclusion Criteria:
- Discontinued IP prematurely in the blinded phase of the study for reasons other than tracheostomy or permanent-assisted ventilation.
- Treatment with or use of any restricted medications.
- Any ongoing AE that, in the opinion of the site investigator, is clear contraindication to the IP.
- Unstable cardiac or other life-threatening disease emergent during the assigned by chance, blinded study
- Any major medical history or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study.
- If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception during the study and for at least 1 month after...
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Orange, California, United States
- San Francisco, California, United States
- New Britain, Connecticut, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Lincoln, Nebraska, United States
- Winston-Salem, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
- Toronto, Ontario, Canada
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Orange, California, United States; San Francisco, California, United States; New Britain, Connecticut, United States; Tampa, Florida, United States; Atlanta, Georgia, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.