A Multi-centered, Double-blind, Randomized, Placebo-controlled Study of TEV-56286 for the Treatment of Multiple System Atrophy

Phase 2

Recruiting

Conditions: Multiple System Atrophy

Interventions: Drug: TEV-56286
Drug: Placebo

Registration Number: 2023-505320-54-00

Lead Sponsor: Teva Branded Pharmaceutical Products R&D LLC

Brief Summary: The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult patients with MSA.

Detailed Description: We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, and Japan

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 103

Inclusion Criteria

Is a male or female ≥30 years old at screening.

Is considered to be “clinically possible” or “clinically probable” MSA as determined by the Gilman criteria.

Is able to ambulate at least 10 meters without the assistance of another person at screening; the use of an assistive device (cane only, not walker) is allowed.

Exclusion Criteria

Has any clinically significant uncontrolled medical or psychiatric condition (treated or untreated), or findings from vital signs, physical examination, electrocardiogram (ECG), or clinical laboratory, other than MSA related, that in the opinion of the investigator could jeopardize or compromise the patient’s ability to participate in the study.

Is severely affected with a UMSARS part IV score of 5.

Is suspected of having a neurodegenerative disease other than MSA, in the opinion of the investigator.

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TEV-56286	TEV-56286	Orally administered capsules once daily
Placebo	Placebo	Orally administered capsules once daily

Primary Outcome Measures

Name	Time	Method
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)		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 Outcome Measures

Name	Time	Method
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		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: 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: 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: 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: 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: 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		Safety endpoints include the following: 3.number (%) of patients who withdraw from treatment due to an adverse event

Trial Locations

Locations (28): Assistance Publique Hopitaux De Paris
🇫🇷
Paris Cedex 13, France
Centre Hospitalier Universitaire De Bordeaux
🇫🇷
Bordeaux, France
Centre Hospitalier Universitaire De Toulouse
🇫🇷
Toulouse, France
Assistance Publique Hopitaux De Marseille
🇫🇷
Marseille, France
Universitaet Leipzig
🇩🇪
Leipzig, Germany
Medical Center - University Of Freiburg
🇩🇪
Freiburg Im Breisgau, Germany
Klinikum der Universitaet Muenchen AöR
🇩🇪
Munich, Germany
Philipps-Universitaet Marburg
🇩🇪
Marburg, Germany
Technische Universitat Dresden
🇩🇪
Dresden, Germany
Universitaetsklinikum Ulm AöR
🇩🇪
Ulm, Germany
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Assistance Publique Hopitaux De Paris
🇫🇷Paris Cedex 13, France
David Grabli
Site contact
+33142162461
david.grabli@aphp.fr