A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy Safety and Efficacy Study
NCT Number: NCT06568237
Acronym: TOPAS-MSA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Multiple System Atrophy
Interventions: DRUG: TEV-56286|DRUG: Placebo
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-06-15
Locations: Teva Investigational Site 15544, Boca Raton, Florida, 33486, United States|Teva Investigational Site 15543, Spokane, Washington, 99202, United States

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.

Primary Outcome Measures: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score, The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Modified UMSARS part I includes 11 items and item scoring is scaled 0-3 using a range of 0 (no impairment) to 3 (severe impairment)., Baseline to Week 48
Secondary Outcome Measures: Change From Baseline in the Total UMSARS Score (Part I and Part II combined), The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. It 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)., Baseline to Week 48|Change From Baseline in the UMSARS Part 1 Score, The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Part I includes a historical review of disease-related impairments, each item in part I achieves a single score using a range of 0 (no impairment) to 4 (severe impairment)., Baseline to Week 48|Change From Baseline in the Clinical Global Impression Scale - Severity (CGI-S), 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., Baseline to Week 48|Change in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score, 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., Baseline to Week 48|Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs), Up to Week 48|Number of Participants Who Withdraw From the Study Due to an Adverse Event, Up to Week 48|Number of Participants Who Withdraw From Treatment Due to an Adverse Event, Up to Week 48|Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value, Up to Week 48|Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value, Up to Week 48|Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings, Up to Week 48