A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study

Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TEV-56286 to see if it can help relieve symptoms in adults with Multiple System Atrophy (MSA), a rare and serious condition that affects movement and coordination. The main goal is to determine how effective TEV-56286 is when taken by mouth over a period of 48 weeks. The study will also check how safe the medication is and how well patients can tolerate it. Participants will be involved for a total of about 56 weeks, which includes an initial screening period and a follow-up visit after the treatment.

To be eligible for the trial, participants must have a diagnosis of MSA and be able to walk at least 10 meters on their own, though using a cane is permitted. They should also be medically stable and not have a history of certain conditions or substance abuse. Women who can become pregnant must have a negative pregnancy test and use effective birth control during the study. This trial is currently recruiting participants, and if you or someone you know is interested, it's important to discuss eligibility and details with the study team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 at screening; the use of assistive device (eg, cane, not walker) is allowed
• • 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 effective birth control methods
• • Additional criteria apply; please contact the investigator for more information
• Exclusion Criteria:
• • 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