A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
- 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.
- Acronym
- TOPAS-MSA
- Short title
- A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
- 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)
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-09-15
- First posted
- 2024-08-23
- Registry last updated
- 2026-07-20
- Primary completion date
- 2027-09-15
- Start date
- 2024-10-02
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06568237
- ClinicalTrials.gov ID
- NCT06568237
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11)
Timeframe: Baseline to Week 48
The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Modified UMSARS part I includes all items with the exclusion of item 11. Item scoring is scaled 0-3 using a range of 0 (no impairment) to 3 (severe impairment).
For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined
Timeframe: Baseline to Week 48
The UMSARS is comprised of 4 parts: part I, historical review of disease-related impairments, 12 items and part II, motor examination, 14 items. As UMSARS is a unified scale, each item in parts I and II achieves a single score using a range of 0 (no impairment) to 4 (severe impairment).
For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined)
Timeframe: Baseline to Week 48
For EU: Change From Baseline in the Modified UMSARS part I score (excluding item 11, item scoring rescaled 0-3)
Timeframe: Baseline to Week 48
Change From Baseline in the UMSARS Part 1 Score
Timeframe: Baseline to Week 48
Change From Baseline in Lateral Ventricle Volume Measured by MRI
Timeframe: Baseline to Week 48
Change From Baseline in the Clinical Global Impression - Severity scale (CGI-S)
Timeframe: Baseline to Week 48
The CGI-S scale permits a global evaluation of the participant's current severity of illness on a Likert type scale ranging from 1 to 7, where 1=normal/not at all ill, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill participants
Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF)
Timeframe: Baseline to Week 48
Change From Baseline in the Patient Global Impression-Severity Scale (PGI-S)
Timeframe: Baseline to Week 48
The PGI-S scale permits an evaluation of the participant's MSA severity, according to the participant. The PGI-S scale rates the participant's MSA severity on a 5-point Likert type scale ranging from 0 (not severe) to 4 (very severe)
Change From Baseline in the Pons volume measured by MRI
Timeframe: Baseline to Week 48
Change From Baseline in the Cerebellar volume measured by MRI
Timeframe: Baseline to Week 48
Change From Baseline in the UMSARS part II score
Timeframe: Baseline to Week 48
Change From Baseline in the UMSARS part IV score
Timeframe: Baseline to Week 48
Change From Baseline in the Two-minute walk test as part of gait assessment
Timeframe: Baseline to Week 48
Change From Baseline in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score
Timeframe: Baseline to Week 48
The 40-item MSA-QoL questionnaire is self-administered and each item is rated on a Likert type scale (0: No problem) to (4: Extreme problem). It is comprised of 3 subscales relevant to MSA: motor (14 items), non-motor (12 items), and emotional/social (14 items). The MSA-QoL total score is the sum of all the items and lower scores indicate better QoL.
Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs)
Timeframe: Up to Week 48
Number of Participants Who Withdraw From the Study Due to an Adverse Event
Timeframe: Up to Week 48
Number of Participants Who Withdraw From Treatment Due to an Adverse Event
Timeframe: Up to Week 48
Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value
Timeframe: Up to Week 48
Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value
Timeframe: Up to Week 48
Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings
Timeframe: Up to Week 48
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 30 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
-
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
-
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
- Teva Investigational Site 15554La Jolla, United StatesRecruiting
- Teva Investigational Site 15545Los Angeles, United StatesNot yet recruiting
- Teva Investigational Site 15547Washington D.C., United StatesRecruiting
- Teva Investigational Site 15544Boca Raton, United StatesActive, not recruiting
- Teva Investigational Site 15555Tampa, United StatesRecruiting
- Teva Investigational Site 15550Chicago, United StatesRecruiting
- Teva Investigational Site 15546Kansas City, United StatesRecruiting
- Teva Investigational Site 15736Boston, United StatesRecruiting
- Teva Investigational Site 15870Farmington Hills, United StatesNot yet recruiting
- Teva Investigational Site 15552Rochester, United StatesRecruiting
- Teva Investigational Site 15549New York, United StatesRecruiting
- Teva Investigational Site 15551New York, United StatesRecruiting
- Teva Investigational Site 15553Durham, United StatesActive, not recruiting
- Teva Investigational Site 15735Hershey, United StatesNot yet recruiting
- Teva Investigational Site 15548Pittsburgh, United StatesRecruiting
- Teva Investigational Site 15874Nashville, United StatesRecruiting
- Teva Investigational Site 15869Georgetown, United StatesNot yet recruiting
- Teva Investigational Site 15873Alexandria, United StatesActive, not recruiting
- Teva Investigational Site 15543Spokane, United StatesActive, not recruiting
- Teva Investigational Site 35290Bordeaux, FranceRecruiting
- Teva Investigational Site 35300Caen, FranceRecruiting
- Teva Investigational Site 35289Marseille, FranceRecruiting
- Teva Investigational Site 35291Paris, FranceRecruiting
- Teva Investigational Site 35292Toulouse, FranceRecruiting
- Teva Investigational Site 32823Beelitz, GermanyRecruiting
And 36 more, listed on the interactive page.
- Related resource (www.tevapharm.com)
- Related resource (topas-msa-study.com)
- Related resource (euclinicaltrials.eu)
- 2023
- 2023-505320-54-00
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Multiple system atrophy Primary condition