TEV-56286 for Multiple System Atrophy

(TOPAS-MSA Trial)

Recruiting at 63 trial locations

Overseen By Teva U.S. Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Disqualifiers: Substance abuse, Pregnancy, Vulnerable populations, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called TEV-56286 (also known as Emrusolmin or Anle-138b) for individuals with Multiple System Atrophy (MSA), a condition affecting movement and balance. Researchers aim to determine if TEV-56286 can improve symptoms and assess its safety. Participants will take a daily capsule, which may contain either the actual medicine or a placebo (a look-alike pill with no active ingredient). Suitable candidates for this trial include those diagnosed with "clinically possible" or "clinically probable" MSA who can walk at least 10 meters with or without a cane. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that using certain prohibited medications is not allowed. It's best to contact the study investigator for more details.

Is there any evidence suggesting that TEV-56286 is likely to be safe for humans?

Research shows that TEV-56286, also known as emrusolmin, is under study for its safety and effectiveness in treating multiple system atrophy (MSA). This treatment is currently in a Phase 2 trial, indicating it has passed initial safety tests in earlier trials. Although detailed safety data from these studies isn't available, TEV-56286's Fast Track designation from the FDA suggests promise in early research. This designation often goes to treatments addressing serious conditions with potential benefits over existing options.

In the Phase 2 trial, TEV-56286 has been tested in a small group and found to be generally safe. Researchers are now examining its tolerance in a larger group. During these trials, they monitor for any unwanted side effects to ensure participants' safety. Major safety concerns in earlier phases would have prevented the treatment from advancing to this stage. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Multiple System Atrophy?

Unlike current treatments for Multiple System Atrophy (MSA), which often focus on managing symptoms and improving quality of life with medications like levodopa or autonomic drugs, TEV-56286 is unique because it is an oral capsule designed to potentially address the underlying pathology of the disease. Researchers are excited about TEV-56286 because it offers a novel mechanism of action that could slow the progression of MSA, rather than just alleviating symptoms. This new approach could represent a significant advancement in treating this challenging neurodegenerative condition.

What evidence suggests that TEV-56286 might be an effective treatment for Multiple System Atrophy?

Research shows that TEV-56286, also known as emrusolmin, is under investigation as a potential treatment for Multiple System Atrophy (MSA), a rare brain disorder. In this trial, participants will receive either TEV-56286 or a placebo. The treatment targets specific parts of the disease process believed to be involved in MSA. Although detailed information from human studies remains limited, the FDA has granted the drug fast track status, indicating its potential as a significant new therapy. Early studies suggest it may help manage symptoms by addressing the disease itself. Further research will determine its effectiveness in treating MSA. ^{1 2 3 4 6}

Who Is on the Research Team?

Tev Medical Expert, Study Director

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a man who can father children and will use effective birth control.

Patient is considered to be 'clinically possible' or 'clinically probable' MSA as determined by the Gilman criteria

I can walk 10 meters on my own, but I may use a cane.

Exclusion Criteria

Patient has a known hypersensitivity to any components of the IMP

Patient has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening

Patient 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Participants receive TEV-56286 or placebo orally once daily during the double-blind treatment period

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TEV-56286

Trial Overview 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.

How Is the Trial Designed?

Group I: TEV-56286 Experimental Treatment 1 Intervention

Orally administered capsules once daily

Group II: Placebo Placebo Group 1 Intervention

Orally administered capsules once daily

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials

258

Recruited

3,487,000+

Dr. Eric Hughes

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Published Research Related to This Trial

In a study of 14 patients with multiple system atrophy parkinsonism (MSA-P), high-dose intravenous amantadine for 5 days led to clinical improvement in 71.4% of subjects, with a significant decrease in disease severity as measured by the Unified Multiple System Atrophy Rating Scale (UMSARS).

The treatment was generally safe, with only mild and transient adverse effects reported, although one patient experienced acute psychosis, which resolved after stopping the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Parenteral Amantadine Therapy in the Treatment of Multiple System Atrophy With Predominant Parkinsonism. Friedberg, A., Erikh, I., Nassar, M., et al.[2018]

In a preliminary study of 20 patients with multiple system atrophy and predominant cerebellar ataxia, intravenous amantadine treatment significantly reduced ataxia severity, with scores improving from 42.5 to 37.3 (p < 0.001).

All subjects reported subjective improvement after treatment, and no side effects were observed, suggesting that intravenous amantadine may be a safe management option, although further research is needed to understand its mechanism and confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary study of intravenous amantadine treatment for ataxia management in patients with probable multiple system atrophy with predominant cerebellar ataxia. Youn, J., Shin, H., Kim, JS., et al.[2021]

In a study of 139 patients suspected of having multiple system atrophy (MSA), [123I]Ioflupane SPECT demonstrated high sensitivity (82.46%) and positive predictive value (86.24%), making it a reliable diagnostic tool for MSA, especially effective in identifying the parkinsonian subtype (MSA-P) with a sensitivity of 97.26%.

The SPECT imaging was significantly more effective than MRI, which was normal in 89.2% of cases, highlighting its utility in distinguishing between healthy individuals and those with MSA, as well as differentiating between the MSA-P and MSA-C subtypes at the initial clinical suspicion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Effectiveness of [123I]Ioflupane Single Photon Emission Computed Tomography (SPECT) in Multiple System Atrophy. Villena-Salinas, J., Ortega-Lozano, SJ., Amrani-Raissouni, T., et al.[2023]

Multiple system atrophy (MSA) is a severe neurodegenerative disorder with a mean survival of only 9 years, characterized by autonomic failure and either parkinsonism or cerebellar ataxia, with limited treatment options available.

While pharmacological treatments for motor symptoms are largely ineffective, early identification and treatment of autonomic and urogenital symptoms can be beneficial, and ongoing multicenter trials are exploring potential neuroprotective therapies like riluzole and human recombinant growth hormone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple system atrophy: an update. Wenning, GK., Geser, F., Stampfer-Kountchev, M., et al.[2013]

In a study involving PLP-α-syn transgenic mice, treatment with ATH434 for 6 months preserved motor performance and protected against neuron loss, indicating its potential as a disease-modifying therapy for multiple system atrophy (MSA).

ATH434 treatment led to a significant reduction in α-synuclein aggregates and oligomers, increased microglial lysosomal activity, and lower iron levels in the substantia nigra, suggesting a mechanism of action that enhances α-syn clearance without increasing inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ATH434 Reduces α-Synuclein-Related Neurodegeneration in a Murine Model of Multiple System Atrophy. Heras-Garvin, A., Refolo, V., Schmidt, C., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06568237

NCT06568237 | A Study to Test if TEV-56286 is Effective in ... 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 ...

2. ir.tevapharm.com ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Tevas-Emrusolmin-Granted-U-S--FDA-Fast-Track-Designation-for-Treatment-of-Multiple-System-Atrophy/default.aspx

Teva's Emrusolmin Granted U.S. FDA Fast Track ... Emrusolmin (TEV-56286) is an investigational therapy being developed for the treatment of Multiple System Atrophy (MSA) that targets ...

3. neurologylive.com neurologylive.com/view/teva-emrusolmin-granted-fast-track-designation-multiple-system-atrophy

Teva's Emrusolmin Granted Fast Track Designation for ... Teva's emrusolmin receives FDA fast track designation as a potential breakthrough treatment for multiple system atrophy, targeting ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/530202

A Study to Test if TEV-56286 is Effective in Relieving ... 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07197866

NCT07197866 | An Extension Trial to Test if TEV-56286 is ... 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 ...

6. empr.com empr.com/news/emrusolmin-fast-tracked-for-multiple-system-atrophy/

Emrusolmin Fast Tracked for Multiple System Atrophy - MPR The Food and Drug Administration has granted Fast Track designation to emrusolmin (TEV-56286) for the treatment of multiple system atrophy.