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Tests treatment safety and results for Prion Disease
Official title PrProfile: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717
ClinicalTrials.gov ID: NCT06153966
What this study is testing
What is ION717?
ION717 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for prion disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intrathecal (IT) delivery of ION717.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key A confirmed diagnosis of probable or definite prion disease.
- Early-stage prion disease at the time of Screening.
- Willing to meet all study requirements, including travel to Study Center, procedures, measurements and visits.
- Patients must have a caregiver who is ≥ 18 years old and who is able and willing to facilitate the patient's involvement, to the best of their...
- Aged ≥ 18 at the time of informed consent. Key
You likely can't join if
- Clinically significant abnormalities in medical history, laboratory tests or physical examination that would render a patient unsuitable for...
- Any contraindication or unwillingness to undergo an MRI.
- Obstructive hydrocephalus, presence of a functional ventriculoperitoneal shunt for the drainage of cerebrospinal fluid (CSF) or an implanted central...
- Known brain or spinal disease that would interfere with the LP process, CSF circulation or safety assessment.
- Have any other condition, which, in the opinion of the Investigator would make the patient unsuitable for inclusion or could interfere with the...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Parkville, Australia
- Montreal, Quebec, Canada
- Paris, France
- Göttingen, Germany
- Tel Aviv, Israel
- Milan, Italy
- Gunma, Isesaki-shi, Japan
- Tokyo, Kodaira-shi, Japan
- Yamaguchi, Shimonoseki-shi, Japan
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Cleveland, Ohio, United States; Parkville, Australia; Montreal, Quebec, Canada; Paris, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.