Recruiting NCT06568237
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TEV-56286, Placebo.
- Who it may be relevant to
- Registry conditions: Multiple System Atrophy. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Germany, Israel, Italy +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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 (TOPAS-MSA)
Overview
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.
Detailed description
We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, Japan, and Serbia.
Interventions
- Drug TEV-56286
TEV-56286 capsules administered orally - Drug Placebo
Matching placebo administered orally
Primary outcome measures
- For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11) [Time frame: Baseline to Week 48]
- For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined [Time frame: Baseline to Week 48]
Secondary outcome measures (12)
- For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined) [Time frame: Baseline to Week 48]
- For EU: Change From Baseline in the Modified UMSARS part I score (excluding item 11, item scoring rescaled 0-3) [Time frame: Baseline to Week 48]
- Change From Baseline in the UMSARS Part 1 Score [Time frame: Baseline to Week 48]
- Change From Baseline in Lateral Ventricle Volume Measured by MRI [Time frame: Baseline to Week 48]
- Change From Baseline in the Clinical Global Impression - Severity scale (CGI-S) [Time frame: Baseline to Week 48]
- Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF) [Time frame: Baseline to Week 48]
- Change From Baseline in the Patient Global Impression-Severity Scale (PGI-S) [Time frame: Baseline to Week 48]
- Change From Baseline in the Pons volume measured by MRI [Time frame: Baseline to Week 48]
- Change From Baseline in the Cerebellar volume measured by MRI [Time frame: Baseline to Week 48]
- Change From Baseline in the UMSARS part II score [Time frame: Baseline to Week 48]
- Change From Baseline in the UMSARS part IV score [Time frame: Baseline to Week 48]
- Change From Baseline in the Two-minute walk test as part of gait assessment [Time frame: Baseline to Week 48]
Eligibility criteria
Inclusion 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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 19 centers
- Teva Investigational Site 15554 — La Jolla
- Teva Investigational Site 15545 — Los Angeles
- Teva Investigational Site 15547 — Washington D.C.
- Teva Investigational Site 15544 — Boca Raton
- Teva Investigational Site 15555 — Tampa
- Teva Investigational Site 15550 — Chicago
- Teva Investigational Site 15546 — Kansas City
- Teva Investigational Site 15736 — Boston
- … and 11 more centers
Spain · 11 centers
- Teva Investigational Site 31328 — Barakaldo
- Teva Investigational Site 31323 — Barcelona
- Teva Investigational Site 31321 — Barcelona
- Teva Investigational Site 31324 — Barcelona
- Teva Investigational Site 31329 — Elche
- Teva Investigational Site 31327 — Madrid
- Teva Investigational Site 31330 — Madrid
- Teva Investigational Site 31331 — Madrid
- … and 3 more centers
Germany · 9 centers
- Teva Investigational Site 32823 — Beelitz
- Teva Investigational Site 32818 — Dresden
- Teva Investigational Site 32822 — Düsseldorf
- Teva Investigational Site 32825 — Kassel
- Teva Investigational Site 32826 — Leipzig
- Teva Investigational Site 32824 — Marburg
- Teva Investigational Site 32820 — München
- Teva Investigational Site 32819 — Münster
- … and 1 more center
Japan · 7 centers
- Teva Investigational Site 84140 — Chiba
- Teva Investigational Site 84139 — Fuchū
- Teva Investigational Site 84136 — Gifu
- Teva Investigational Site 84137 — Niigata
- Teva Investigational Site 84138 — Sagamihara
- Teva Investigational Site 84141 — Sanda-shi
- Teva Investigational Site 84135 — Sendai
Italy · 6 centers
- Teva Investigational Site 30299 — Bologna
- Teva Investigational Site 30297 — Catania
- Teva Investigational Site 30298 — Milan
- Teva Investigational Site 30294 — Padova
- Teva Investigational Site 30296 — Roma
- Teva Investigational Site 30295 — Salerno
France · 5 centers
- Teva Investigational Site 35290 — Bordeaux
- Teva Investigational Site 35300 — Caen
- Teva Investigational Site 35289 — Marseille
- Teva Investigational Site 35291 — Paris
- Teva Investigational Site 35292 — Toulouse
Israel · 3 centers
- Teva Investigational Site 80203 — Haifa
- Teva Investigational Site 80215 — Jerusalem
- Teva Investigational Site 80204 — Tel Aviv
Serbia · 1 center
- Teva Investigational Site 61808 — Belgrade
Identifiers
NCT: NCT06568237 · TV56286-NDG-20039 · 2023-505320-54-00