We are seeking adult participants for an extension trial evaluating the long-term safety and tolerability of the oral study medication, TEV-56286. Your participation can help drive medical research forward.
The primary objective of this clinical trial is to describe the long-term safety and tolerability of the investigational medication, TEV-56286, administered orally. A secondary objective is to further evaluate how the body processes and responds to the treatment over an extended period.
This research is dedicated to adult participants diagnosed with Multiple System Atrophy (MSA). By participating, you contribute to vital scientific research aimed at better understanding and potentially improving the management of this condition.
A thorough review of your medical history and completion of the initial double-blind trial requirements to ensure this extension study is a safe and appropriate fit for you.
Participants will receive oral administration of the investigational medication over the planned duration of the trial.
Regular health check-ins and assessments with our dedicated medical team to carefully monitor your safety, tolerability, and overall well-being.
To ensure patient safety and scientific rigor, this clinical trial has specific requirements. Please review the general guidelines below.
As a participant in the TEV-56286 extension trial for Multiple System Atrophy (MSA), you will receive dedicated medical monitoring and support without cost to you.
Receive the investigational oral medication (TEV-56286) at no cost throughout the 100-week trial duration.
Undergo regular, comprehensive health assessments and gain ongoing access to doctors specializing in MSA.
Contribute meaningfully to the scientific understanding of long-term safety and tolerability for potential MSA treatments.
We want you to feel completely comfortable and informed. Here are clear answers to common questions regarding this Multiple System Atrophy (MSA) extension trial.
Clinical trials are carefully designed research studies that evaluate the safety and effectiveness of medical treatments. Participant safety is our absolute highest priority. This trial is rigorously monitored by medical professionals, ethical review boards, and health authorities to ensure strict, ongoing safety protocols are maintained.
The planned total duration for this specific extension trial is approximately 100 weeks. During this period, you will have regular visits and health assessments with the study team to closely monitor your well-being and progress.
As with any clinical research, there may be risks involved. The primary objective of this trial is to thoroughly describe the long-term safety and tolerability of TEV-56286. Before you agree to participate, the study doctor will provide a detailed explanation of all known potential risks, side effects, and expected benefits.
Yes, absolutely. We maintain strict confidentiality protocols. All of your personal and medical information collected during the study is securely stored and protected in full compliance with national healthcare privacy regulations. Your identity will never be disclosed in any study reports.
Yes. Your participation is completely voluntary. You have the fundamental right to withdraw from the study at any time, for any reason, without needing to explain why. Leaving the study will not result in any penalty or affect the quality of your standard medical care.
Because this is an extension trial specifically for participants who have completed the initial double-blind study (TV56286-NDG-20039), the study doctor will explain exactly how the investigational medication is administered during this new phase. Please discuss your specific treatment plan directly with the study team.
After the approximately 100-week period concludes, the study team will conduct final, comprehensive health assessments. Your study doctor will then discuss the results with you and help determine the best next steps for your ongoing care and management of Multiple System Atrophy.