300 Participants NeededMy employer runs this trial

NIO752 for Progressive Supranuclear Palsy

Recruiting at 39 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novartis Pharmaceuticals
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests NIO752, a potential new treatment for Progressive Supranuclear Palsy (PSP), a rare brain disorder affecting movement, balance, and eye movements. Participants will receive either NIO752 or a placebo to evaluate the treatment's effectiveness and safety. It suits individuals diagnosed with mild-to-moderate PSP Richardson syndrome who can walk at least 10 steps with little or no assistance. Participants need a reliable partner, such as a spouse or friend, to assist during the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that NIO752 is likely to be safe for humans?

Research has shown that NIO752 underwent safety testing in people with Progressive Supranuclear Palsy (PSP) in earlier studies. In these studies, patients received various doses to assess their tolerance to the drug. Results indicated that participants generally tolerated NIO752 well. Some side effects occurred, but they were usually mild. Headaches and nausea were the most common issues, typical in many clinical trials. These safety findings support further research on NIO752 in PSP. The current trial's late stage indicates that earlier trials provided positive safety data.12345

Why do researchers think this study treatment might be promising for PSP?

NIO752 is unique because it specifically targets the tau protein, which is believed to play a key role in the progression of Progressive Supranuclear Palsy (PSP). Unlike standard treatments that often focus on managing symptoms with medications like levodopa or amantadine, NIO752 aims to address the underlying disease process itself. Researchers are excited about NIO752 because it could potentially slow or halt disease progression, offering hope for a more effective treatment beyond mere symptom relief.

What evidence suggests that NIO752 might be an effective treatment for Progressive Supranuclear Palsy?

Research has shown that NIO752 is being developed to treat Progressive Supranuclear Palsy (PSP), a condition caused by harmful protein build-up in the brain. Early studies have examined the drug's safety and mechanism of action. NIO752 targets these protein clumps, which are believed to damage brain cells. Initial trials indicated that NIO752 is safe and well-tolerated by patients. Although detailed results on its effectiveness are not yet available, promising scientific research supports the treatment. Participants in this trial will receive either NIO752 or a placebo to further evaluate its safety and effectiveness.12367

Are You a Good Fit for This Trial?

This trial is for adults aged 41-81 with mild to moderate Progressive Supranuclear Palsy (PSP) diagnosed within the last 5 years. Participants must be able to walk at least 10 steps, have a reliable caregiver or partner, and score at least 20 on a mental status test.

Inclusion Criteria

I am between 41 and 81 years old.
4. PSPRS total score less than 40 at Baseline.
1. Signed informed consent must be obtained prior to participation in the study.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NIO752 or placebo in a double-blind manner

72 weeks

Open-label extension

Participants may opt into continuation of NIO752 treatment long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NIO752

Trial Overview

The study compares NIO752, an investigational drug, against a placebo in people with PSP. Participants are randomly assigned to either group and may later receive NIO752 in an open-label extension phase.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NIO752Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

A Study to Evaluate the Efficacy of NIO752 in Participants ...

This Phase III study is intended to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy (PSP).

A clinical trial to learn about the safety of NIO752 in people ...

The purpose of this trial was to learn about the safety of different doses of NIO752 in people with progressive supranuclear palsy. Progressive supranuclear ...

Novartis Provides Update on PRESERVE, a Phase 3 ...

A previous Phase 1 trial tested the safety and pharmacodynamics of NIO752 in people with PSP, and a trial testing NIO752 in Alzheimer's disease ...

NIO752

NIO752 is in development to treat progressive supranuclear palsy, a primary tauopathy caused by accumulation of aggregates containing the 4 ...

A Study to Evaluate the Efficacy of NIO752 in Participants With ...

This Phase III study is intended to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy (PSP).

Sponsor Generic Drug Name Trial Indication(s) Protocol ...

These safety and tolerability data coupled with PK findings support the future development of NIO752 in the PSP program. Date of Clinical Trial ...

Clinical Trials

A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of NIO752 In Participants With Progressive Supranuclear Palsy. Print details. Share; Facebook ...