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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505320-54-00
Acronym
TV56286-NDG-20039
Enrollment
103
Registered
2024-04-16
Start date
2025-01-30
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple System Atrophy

Brief summary

The primary efficacy endpoint (TEV-56286 versus placebo, change from baseline to week 48) is as follows: • modified UMSARS part I (excluding item 11, item scoring rescaled 0-3)

Detailed description

The Secondary efficacy endpoints (TEV-56286 versus placebo, change from baseline to week 48) are as follows: • total UMSARS score (part I and part II combined) • UMSARS part I score • CGI-S • MSA-QoL, Safety endpoints include the following: 1. number (%) of participants per adverse events, Safety endpoints include the following: 2. number (%) of patients who withdraw from the study due to an adverse event, Safety endpoints include the following: 4. number (%) of patients with potentially clinically significant vital sign values, Safety endpoints include the following: 5. number (%) of patients with potentially clinically significant laboratory test values (hematology and chemistry), Safety endpoints include the following: 6. number (%) of patients with potentially clinically significant changes in 12-lead ECG measurements, Safety endpoints include the following: 3.number (%) of patients who withdraw from treatment due to an adverse event

Interventions

DRUGPlacebo to match IMP TEV-56286

Sponsors

Teva Branded Pharmaceutical Products R&D LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary efficacy endpoint (TEV-56286 versus placebo, change from baseline to week 48) is as follows: • modified UMSARS part I (excluding item 11, item scoring rescaled 0-3)

Secondary

MeasureTime frame
The Secondary efficacy endpoints (TEV-56286 versus placebo, change from baseline to week 48) are as follows: • total UMSARS score (part I and part II combined) • UMSARS part I score • CGI-S • MSA-QoL, Safety endpoints include the following: 1. number (%) of participants per adverse events, Safety endpoints include the following: 2. number (%) of patients who withdraw from the study due to an adverse event, Safety endpoints include the following: 4. number (%) of patients with potentially clinically significant vital sign values, Safety endpoints include the following: 5. number (%) of patients with potentially clinically significant laboratory test values (hematology and chemistry), Safety endpoints include the following: 6. number (%) of patients with potentially clinically significant changes in 12-lead ECG measurements, Safety endpoints include the following: 3.number (%) of patients who withdraw from treatment due to an adverse event

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026