A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy

Phase
Recruitment status
Participants
Lead sponsor
Teva Branded Pharmaceutical Products R&D LLC
Start date
Number of sites

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
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
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Teva Branded Pharmaceutical Products R&D LLC
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design

  1. 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).

  2. 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).

  1. For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined)

    Timeframe: Baseline to Week 48

  2. 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

  3. Change From Baseline in the UMSARS Part 1 Score

    Timeframe: Baseline to Week 48

  4. Change From Baseline in Lateral Ventricle Volume Measured by MRI

    Timeframe: Baseline to Week 48

  5. 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

  6. Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF)

    Timeframe: Baseline to Week 48

  7. 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)

  8. Change From Baseline in the Pons volume measured by MRI

    Timeframe: Baseline to Week 48

  9. Change From Baseline in the Cerebellar volume measured by MRI

    Timeframe: Baseline to Week 48

  10. Change From Baseline in the UMSARS part II score

    Timeframe: Baseline to Week 48

  11. Change From Baseline in the UMSARS part IV score

    Timeframe: Baseline to Week 48

  12. Change From Baseline in the Two-minute walk test as part of gait assessment

    Timeframe: Baseline to Week 48

  13. 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.

  14. Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs)

    Timeframe: Up to Week 48

  15. Number of Participants Who Withdraw From the Study Due to an Adverse Event

    Timeframe: Up to Week 48

  16. Number of Participants Who Withdraw From Treatment Due to an Adverse Event

    Timeframe: Up to Week 48

  17. Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value

    Timeframe: Up to Week 48

  18. Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value

    Timeframe: Up to Week 48

  19. Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings

    Timeframe: Up to Week 48

Sources for outcomes

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
Sources for eligibility

  • 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.

Sources for sites

  • 2023
  • 2023-505320-54-00
Sources for references

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)