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Antisense Oligonucleotide for Progressive Supranuclear Palsy
Study Summary
This trial is investigating a new drug for PSP, a degenerative brain disease. The drug will be given to a small group of people to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a diagnosed neurological condition that could explain my symptoms.My Parkinson's or Alzheimer's medication dose has been stable for at least 30 days.You have recently shown signs of wanting to harm yourself or others, have had a major episode of feeling very sad, confused, or violent.I have had issues with balance or falls for at least a year within the first three years of my disease.I am between 40 and 75 years old.You live in a nursing home or a place for people with memory problems.I have difficulty moving my eyes up or down quickly.I can safely have lumbar punctures and blood tests.I've had severe headaches or needed a blood patch after a lumbar puncture.I have not been hospitalized for a major procedure under general anesthesia in the last 12 weeks and have no such plans during the study.You cannot have an MRI or have medical reasons that make MRI unsafe for you.You have a significant abnormality in your lab test results.I was diagnosed with PSP less than 5 years ago, my condition is likely PSP Richardson syndrome, and my health scores are within a specific range.I have had balance problems or falls for at least a year within the first three years of my disease.I have not taken any drugs for PSP or experimental therapy recently.I was diagnosed with PSP less than 5 years ago, have probable PSP Richardson syndrome, a PSPRS score under 40, and a MOCA score over 17.My medication doses have been stable for the last 30 days and will remain so.I have someone over 18 who can come with me to my study visits and knows about my health condition.I can have spinal taps and blood tests.I have seen significant improvement with levodopa treatment.I am at high risk for meningitis but am on preventive treatment.You have other important brain abnormalities found in your medical history or during the screening process.I can walk on my own or with little help.I am between 40 and 75 years old.I have difficulty moving my eyes up or down quickly.I can walk on my own or with little help.
- Group 1: Cohort A NIO752
- Group 2: Cohort B NIO752
- Group 3: Placebo
- Group 4: Cohort C NIO752
- Group 5: Cohort D NIO752
- Group 6: Cohort E NIO752
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the Federal Drug Administration approved antisense oligonucleotide for public use?
"As this is a Phase 1 trial, the safety of antisense oligonucleotides has been appraised as low or 1. This suggests that while there is limited data to support efficacy and safety, it still requires clinical trials for further evaluation."
Is it possible to participate in this medical experiment?
"This clinical trial is recruiting 66 individuals afflicted with paralysis, ranging in age from 40 to 75 years old. It is critical that they meet the following prerequisites: no alterations should be made to their Parkinson's or Alzheimer's medications for at least a month prior and throughout the study; 12 months of postural instability must have been documented within 3 years of disease onset; PSP Richardson Syndrome diagnosis within 5 years and its concomitant scores on MOCA Test >17 and PSPRS <40; vertical supranuclear gaze palsy or reduced velocity of saccades verified ; access to an 18+ year-old reliable participant partner available"
Is the age cutoff for this trial 18 years or older?
"This clinical trial will accept patients aged 40 to 75 years of age."
Is the research team actively seeking participants for this experiment?
"Affirmative. Clinicaltrials.gov's data indicates that this clinical trial is currently recruiting patients - the study was initially posted on February 16th 2021 and updated most recently on February 23rd 2022. The entirety of 66 participants will be recruited from 5 different sites."
What is the current sample size for this experiment?
"Affirmative, the information on clinicaltrials.gov demonstrates that this research is actively seeking enrolment. This medical trial was initially posted in February of 2021 and was most recently revised in late February 2022; it seeks to recruit 66 patients from 5 sites."
What is the ultimate aim of this research endeavor?
"Across the course of one year, researchers will be measuring a range of primary and secondary outcomes. The former include adverse events and serious adverse events while the latter involve AUCinf in blood plasma (mass x time x volume-1), concentrations of NIO752 in blood plasma, as well as Tmax post first injection."
Are there copious facilities conducting this exploration in Canada?
"This experiment is currently being conducted in 5 locations, including but not limited to Montreal, Boca Raton and La Jolla. It's beneficial for any potential participants to select the closest site so as to reduce travel commitments if they decide to join the study."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Average response time
- < 2 Days
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