Summary

Eligibility
for people ages 30-75 (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

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.

Another secondary objective is to evaluate the safety and tolerability of TEV-56286.

The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.

Official Title

A Multi-centered, Double-blind, Randomized, Placebo-controlled, Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy

Details

We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, and Japan

Keywords

Multiple System Atrophy, Multiple System Atrophy (MSA), 3-(1,3-benzodioxol-5-yl)-5-(3-bromophenyl)-1H-pyrazole, TEV-56286

Eligibility

You can join if…

Open to people ages 30-75

  • 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 effective birth control methods
    • Additional criteria apply; please contact the investigator for more information

You 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 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

Locations

  • Teva Investigational Site 15545 accepting new patients
    Los Angeles 5368361 California 5332921 90095 United States
  • Teva Investigational Site 15554 accepting new patients
    La Jolla 5363943 California 5332921 92037 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Links
TOPAS-MSA Web Site Teva MSA Trial EU Locations
ID
NCT06568237
Phase
Phase 2 Multiple System Atrophy Research Study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated