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New treatment option for Multiple System Atrophy
Official title A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
ClinicalTrials.gov ID: NCT06568237
What this study is testing
What is TEV-56286?
TEV-56286 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for multiple system atrophy.
Also referred to as emrusolmin, anle138b.
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
- The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75
You may be able to join if
- is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria
- is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination
- Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits
- Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods
- Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are...
You likely can't join if
- has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA
- has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior...
- has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening
- is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study
- has a known hypersensitivity to any components of the IMP
- is of a vulnerable population (eg, people kept in detention or jail)
See the full eligibility criteria
- is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria
- is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination
- Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits
- Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods
- Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly...
- Additional criteria apply; please contact the investigator for more information
- has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA
- has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening
- has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening
- is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study
- has a known hypersensitivity to any components of the IMP
- is of a vulnerable population (eg, people kept in detention or jail)
- participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study
- Additional criteria apply; please contact the investigator for more information
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Boca Raton, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Farmington Hills, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Hershey, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Georgetown, Texas, United States
- Alexandria, Virginia, United States
- Spokane, Washington, United States
- Bordeaux, France
- Caen, France
+ 36 more site(s).
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, 30 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Boca Raton, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States and 50 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.