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A Multi-centered, Double-blind, Randomized, Placebo-controlled Study of TEV-56286 for the Treatment of Multiple System Atrophy
EU CTIS ID: 2023-505320-54-00
What this study is testing
The primary objective of the trial is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with MSA.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is a male or female aged ≥30 to ≤75 years old at screening
- Is considered to be “clinically possible” or “clinically probable” MSA as determined by the Gilman criteria.
- Is able to ambulate at least 10 meters without the assistance of another person. Use of an assistive device (cane only, not walker) is allowed during this assessment. Apart from the 10-meter walk at screening, use of any assistive device is allowed during the trial.
You likely can't join if
- Has any clinically significant uncontrolled medical or psychiatric condition (treated or untreated), or any findings from vital signs, imaging, physical examination, electrocardiogram (QTcF >450 msec), or clinical laboratory, other than MSA related, that could jeopardize or compromise the participant’s safety, ability to participate, or integrity of the trial. The investigator should consult with the medical monitor or trial physician as needed.
- Is severely affected with a UMSARS part IV score of > 3
- Is suspected of having a neurodegenerative disease other than MSA
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
- Japan
- Serbia
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States; Japan; Serbia. 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 EU CTIS; the study team decides eligibility.