XT-150 for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called XT-150 for individuals with Amyotrophic Lateral Sclerosis (ALS), a condition that causes muscle weakness and affects nerve control over muscles. The main goal is to determine the safety of XT-150, with participants receiving a single dose through an injection into the spinal canal. The trial includes two groups, each receiving different dose levels of XT-150. Suitable candidates for this trial have been diagnosed with ALS, have experienced muscle weakness symptoms for less than three years, and can handle the study's procedures. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that you should not be taking any prohibited medications. If you are on a stable dose of an approved ALS treatment, you may continue with it, but you cannot be on Tofersen.
Is there any evidence suggesting that XT-150 is likely to be safe for humans?
Current studies are testing XT-150 for safety in people with ALS, a disease affecting nerve cells in the brain and spinal cord. As a Phase 1 study, researchers are primarily assessing the safety of XT-150 and its tolerability in humans. No information on side effects for XT-150 in ALS exists yet, as this is its first human trial for the condition.
Phase 1 studies are typically small and focus on safety. If XT-150 passes this phase without major issues, it generally suggests good tolerability. However, since XT-150 is not yet approved for any condition, its safety profile remains under evaluation. Participants will receive either a low or higher dose of XT-150 through a spinal injection, and researchers will closely monitor them for any side effects over six months.12345Why do researchers think this study treatment might be promising for ALS?
Most treatments for ALS focus on managing symptoms and include medications like riluzole and edaravone, which aim to slow the progression of the disease. However, XT-150 is unique because it is delivered directly into the spinal canal through an intrathecal injection, potentially allowing for more targeted action. Researchers are excited about XT-150 because it could provide a new way of addressing ALS by reaching the nervous system directly, which might enhance its effectiveness compared to current oral or intravenous treatments. This direct delivery method could lead to more significant impacts on disease progression and patient outcomes.
What evidence suggests that XT-150 might be an effective treatment for ALS?
Research suggests that XT-150 could benefit people with ALS (Amyotrophic Lateral Sclerosis). In this trial, participants will receive either 1.5 mg or 4.5 mg of XT-150, administered by intrathecal injection. Some studies have shown that just one injection of XT-150 may have long-lasting effects. Early results also indicate safety and effectiveness, with only minor side effects reported. In animal studies, a similar drug improved symptoms and increased survival rates. Although human studies provide limited information, these findings offer hope for its effectiveness in treating ALS.12367
Are You a Good Fit for This Trial?
This trial is for adults with Amyotrophic Lateral Sclerosis (ALS), a type of motor neuron disease. Participants must provide informed consent and meet all study requirements to receive a single injection of XT-150 and be followed up for 6 months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intrathecal injection of XT-150 at the Baseline visit
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events, vital signs, and laboratory assessments
What Are the Treatments Tested in This Trial?
Interventions
- XT-150
Find a Clinic Near You
Who Is Running the Clinical Trial?
Xalud Therapeutics, Inc.
Lead Sponsor