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TEV-56286 for Multiple System Atrophy (TOPAS-MSA Trial)

Phase 2
Recruiting
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is able to ambulate at least 10 meters without the assistance of another person at screening; the use of assistive device (eg, cane, not walker) is allowed
Patient is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination
Must not have
Participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study
Female participant who is pregnant or breastfeeding, or plans to become pregnant during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 48
Awards & highlights

Summary

This trial aims to test the effectiveness of TEV-56286 in treating adults with Multiple System Atrophy. The study will also look at specific efficacy parameters and the safety of TEV-56286

Who is the study for?
This trial is for adults with Multiple System Atrophy (MSA), a progressive neurological disorder. Participants must be able to take oral medication and commit to the study duration of about 56 weeks, including follow-up.
What is being tested?
The trial is testing TEV-56286's effectiveness in relieving symptoms of MSA compared to a placebo. It involves taking the drug orally over a period of 48 weeks, with specific efficacy parameters being evaluated alongside safety and tolerability.
What are the potential side effects?
While the side effects are not detailed here, common considerations include potential gastrointestinal issues, allergic reactions, or other drug-related intolerances that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk 10 meters on my own, but I may use a cane.
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I am stable both physically and mentally, according to my doctors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications that are not allowed in this study.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score
Secondary study objectives
Change From Baseline in the Clinical Global Impression Scale - Severity (CGI-S)
Change From Baseline in the Total UMSARS Score (Part I and Part II combined)
Change From Baseline in the UMSARS Part 1 Score
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TEV-56286Experimental Treatment1 Intervention
Orally administered capsules once daily
Group II: PlaceboPlacebo Group1 Intervention
Orally administered capsules once daily

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Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
253 Previous Clinical Trials
3,485,618 Total Patients Enrolled
1 Trials studying Multiple System Atrophy
174 Patients Enrolled for Multiple System Atrophy
Tev Medical Expert, Study DirectorStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
~133 spots leftby May 2027
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