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An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy

NCT ID: NCT07197866

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2029-05-17

Brief Summary

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The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).

A secondary objective of the trial is to further describe the safety and tolerability of TEV-56286.

The planned total duration of the trial is approximately 100 weeks.

Detailed Description

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Conditions

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Multiple System Atrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TEV-56286

Group Type EXPERIMENTAL

TEV-56286

Intervention Type DRUG

administered orally

Interventions

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TEV-56286

administered orally

Intervention Type DRUG

Other Intervention Names

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Emrusolmin

Eligibility Criteria

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Inclusion Criteria

* Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements
* Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit
* Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP
* Males who are potentially fertile/reproductively competent (not surgically \[eg, vasectomy\] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product

NOTE - Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

* Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial
* Is of a vulnerable population (eg, people kept in detention or jail)
* Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial

Note - Additional criteria apply, please contact the investigator for more information
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D LLC

Locations

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Teva Investigational Site 15544

Boca Raton, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15543

Spokane, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Teva U.S. Medical Information

Role: CONTACT

[email protected]
1-888-483-8279

Other Identifiers

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2025-521642-14-00

Identifier Type: CTIS

Identifier Source: secondary_id

TV56286-NDG-20041

Identifier Type: -

Identifier Source: org_study_id