TEV-56286 for Multiple System Atrophy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of a new oral medication, TEV-56286, for individuals with Multiple System Atrophy (MSA), a rare disorder affecting movement and balance. The goal is to assess how well patients manage long-term use of the medication. The trial spans about 100 weeks and suits those who have completed a previous related study with the same medication. Individuals with MSA who meet these criteria may find this trial suitable. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial information mentions that some medications might be prohibited, but it doesn't specify which ones. It's best to contact the trial investigator for details about your specific medications.
Is there any evidence suggesting that TEV-56286 is likely to be safe for humans?
Research shows that the FDA has granted "fast track" status to TEV-56286, indicating it as a promising treatment for Multiple System Atrophy (MSA). This status often suggests that the drug has demonstrated potential benefits that outweigh risks in earlier tests, indicating a good safety profile.
In previous studies, researchers tested TEV-56286 on people with MSA. Although detailed safety data is not provided here, the continuation of trials suggests it was generally well-tolerated with manageable side effects. The ongoing research aims to confirm its long-term safety. So far, there have been no reports of serious side effects, which is encouraging for those considering joining the trial.12345Why do researchers think this study treatment might be promising for MSA?
TEV-56286 is unique because it introduces a novel approach to treating Multiple System Atrophy (MSA), a condition for which there are currently limited treatment options mainly focusing on managing symptoms, such as autonomic dysfunction and movement disorders, rather than altering disease progression. Unlike current therapies, TEV-56286 may target the underlying disease mechanisms, offering potential neuroprotective benefits. Researchers are excited about TEV-56286 because it could provide a breakthrough in slowing down or even halting the progression of MSA, potentially improving quality of life for patients.
What evidence suggests that TEV-56286 might be an effective treatment for Multiple System Atrophy?
Studies have shown that TEV-56286, also known as Emrusolmin, is under development as a potential treatment for Multiple System Atrophy (MSA). The FDA has granted it fast track designation, recognizing it as a promising new therapy for this condition. The drug targets specific pathways in the body believed to be involved in MSA, aiming to slow the disease's progression. Although no treatment has been proven to completely stop MSA, TEV-56286 seeks to address this gap by altering the disease's development. Early signs suggest it could improve the management of MSA symptoms.12367
Who Is on the Research Team?
Teva Medical Expert, MD
Principal Investigator
Teva Branded Pharmaceutical Products R&D LLC
Are You a Good Fit for This Trial?
This trial is for adults with Multiple System Atrophy who completed a previous TEV-56286 trial and were compliant. Women able to have children must test negative for pregnancy and use effective birth control, as should men with fertile partners.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TEV-56286 orally for the treatment of Multiple System Atrophy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TEV-56286
Find a Clinic Near You
Who Is Running the Clinical Trial?
Teva Branded Pharmaceutical Products R&D LLC
Lead Sponsor