What side effects are associated with this type of intervention?

Common treatments for Progressive Supranuclear Palsy (PSP) include medications like levodopa and amantadine. Known side effects of these treatments can include nausea, dizziness, somnolence, and application site reactions (for transdermal formulations). Levodopa, often combined with carbidopa, may also lead to dyskinesias and motor fluctuations over time. Amantadine can cause side effects such as confusion, hallucinations, and peripheral edema. It is important to monitor these side effects and adjust treatment as necessary under the guidance of a healthcare provider.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments that alter the natural history of Progressive Supranuclear Palsy (PSP) or provide significant symptomatic benefit for its motor symptoms. Management of PSP is primarily symptomatic, focusing on alleviating specific issues such as eyelid-opening apraxia and blepharospasm with treatments like botulinum toxin therapy. The TPN-101 trial is investigating a new treatment, but its mechanism of action is not specified in the provided context.

What other types of research exist?

Promising novel alternatives to TPN-101 for PSP patients could include treatments being explored for other neurodegenerative diseases. For instance, antisense oligonucleotide therapies, which are being trialed for ALS (e.g., Tofersen for SOD1 ALS), and cholinesterase inhibitors like Galantamine, which is used for Alzheimer's disease, might offer potential. Additionally, drugs targeting amyloidogenesis, such as Tolcapone for amyloidosis, could be considered. However, specific clinical trials for PSP should be consulted for the most relevant and up-to-date options.

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TPN-101 for Progressive Supranuclear Palsy

Phase 2

Waitlist Available

Research Sponsored by Transposon Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

Summary

This trial tests a new drug, TPN-101, to see if it is safe and can be tolerated by patients with Progressive Supranuclear Palsy (PSP). PSP is a rare brain disorder that affects movement and balance. The study will check if TPN-101 can help with symptoms or slow down the disease.

Who is the study for?

This trial is for patients with Progressive Supranuclear Palsy (PSP) who've had symptoms for less than 5 years and have a probable PSP diagnosis. Participants need to score at least 18 on the Mini Mental State Exam, live outside of nursing facilities, and have a reliable caregiver. It's not for those with certain genetic mutations or significant neurological, psychiatric, or other serious health issues.

What is being tested?

The study tests the safety and tolerability of TPN-101 at different doses (100 mg/day, 200 mg/day, and 400 mg/day) compared to a placebo in people with PSP. The goal is to find out how well patients handle the medication.

What are the potential side effects?

While specific side effects are not listed here, generally this phase assesses any adverse reactions ranging from mild discomforts like headaches or nausea to more severe conditions that could affect organ function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the safety and tolerability of TPN-101 in patients with progressive supranuclear palsy (PSP)

Secondary study objectives

Assess the clinical effect of TPN-101 as measured by changes in score on the Progressive Supranuclear Palsy Rating Scale (PSPRS)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: TPN-101, Dose CExperimental Treatment1 Intervention

Group II: TPN-101, Dose BExperimental Treatment1 Intervention

Group III: TPN-101, Dose AExperimental Treatment1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Progressive Supranuclear Palsy (PSP) generally focus on neuroprotection, neurotransmitter modulation, and symptomatic relief. Neuroprotective agents aim to slow the progression of neuronal degeneration, potentially preserving motor and cognitive functions for a longer period. Neurotransmitter modulators, such as those affecting dopamine or acetylcholine pathways, help to manage symptoms like rigidity, bradykinesia, and balance issues. Symptomatic treatments, including physical therapy and medications for mood or sleep disturbances, improve overall quality of life. These mechanisms are vital for PSP patients as they address both the underlying disease process and the debilitating symptoms, offering a more comprehensive management approach.

Postoperative Treatment of Distal Radius Fractures Using Sensorimotor Rehabilitation.Muscle synergies demonstrate only minimal changes after treatment in cerebral palsy.Neurorehabilitation Improves the Motor Features in Prodromal SCA2: A Randomized, Controlled Trial.

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Who is running the clinical trial?

Transposon Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

58 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04993768 — Phase 2

Progressive Supranuclear Palsy Research Study Groups: TPN-101, Dose C, TPN-101, Dose B, TPN-101, Dose A, Placebo

Progressive Supranuclear Palsy Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04993768 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04993768 — Phase 2

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