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Tests treatment safety and results for Progressive Supranuclear Palsy Richardson Syndrome...
Official title A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy
ClinicalTrials.gov ID: NCT07498426
What this study is testing
- What it's testing
- This Phase III study is intended to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy (PSP). Eligible participants will be randomized to receive either NIO752 or placebo followed by an open-label extension.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. 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 41 to 81
You may be able to join if
- Signed informed consent must be obtained prior to participation in the study.
- Male or female participants, age between 41-81 yrs inclusive.
- Diagnosis of mild-moderate, probable/possible PSP Richardson syndrome as per MDS-PSP 2017 criteria with symptoms onset \< 5 years.
- PSPRS total score less than 40 at Baseline.
- Reliable study partner such as spouse, sibling, close friend, or caregiver able and willing to provide accurate information (including clinical...
You likely can't join if
- Diagnosis of other significant neurological or psychiatric disorders including (but not limited to) Parkinsons' Disease (which has not subsequently...
- Diagnosis of amyotrophic lateral sclerosis or other motor neuron diseases.
- Diagnosis of cerebellar ataxia, choreoathetosis, and early symptomatic autonomic dysfunction.
- History of or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct \>1 cm3, \>3...
- Contraindications to undergo MRI procedure, including metal (ferromagnetic) implants and/or a cardiac pacemaker that is not compatible with MRI.
- Medical conditions that would, as per Investigator's judgement, prevent the participant from undergoing lumbar puncture, including but not limited to:
See the full eligibility criteria
- Signed informed consent must be obtained prior to participation in the study.
- Male or female participants, age between 41-81 yrs inclusive.
- Diagnosis of mild-moderate, probable/possible PSP Richardson syndrome as per MDS-PSP 2017 criteria with symptoms onset \< 5 years.
- PSPRS total score less than 40 at Baseline.
- Reliable study partner such as spouse, sibling, close friend, or caregiver able and willing to provide accurate information (including clinical symptoms and medical history) about the participant and to participate in...
- Participant is able to ambulate defined as the ability to take at least 10 steps independently or with minimal assistance (stabilization of one arm to minimize fall risk).
- Mini Mental State Examination (MMSE) score ≥ 20 at Screening.
- Diagnosis of other significant neurological or psychiatric disorders including (but not limited to) Parkinsons' Disease (which has not subsequently been revised to a diagnosis of PSP); Alzheimer's disease (AD), dementia...
- Diagnosis of amyotrophic lateral sclerosis or other motor neuron diseases.
- Diagnosis of cerebellar ataxia, choreoathetosis, and early symptomatic autonomic dysfunction.
- History of or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct \>1 cm3, \>3 lacunar infarcts, cerebral contusion, aneurysm, vascular malformation...
- Contraindications to undergo MRI procedure, including metal (ferromagnetic) implants and/or a cardiac pacemaker that is not compatible with MRI.
- Medical conditions that would, as per Investigator's judgement, prevent the participant from undergoing lumbar puncture, including but not limited to:
- Known allergy to local anesthetic
- History of back surgery (with the exception of microdiscectomy or laminectomy over 1 level)
- Spinal deformities
- Current dermatological infection at the lumbar puncture spot and/or significant skin alterations at the planned puncture place
- Risk of increased or uncontrolled bleeding and/or risk of bleeding that if not managed optimally, could place a participant at an increased risk for procedural bleeding. These could include, but are not limited, to...
- History of deep brain stimulator surgery other than sham surgery for participation in a deep brain stimulation clinical trial. Other protocol-defined inclusion/exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Englewood, Colorado, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
- Melbourne, Victoria, Australia
- Caen, France
- Créteil, France
- Paris, France
- Toulouse, France
- Bonn, North Rhine-Westphalia, Germany
- Düsseldorf, North Rhine-Westphalia, Germany
- Leipzig, Saxony, Germany
- Berlin, Germany
- Stadtroda, Germany
- Ulm, Germany
- Milan, MI, Italy
- Roma, RM, Italy
- Kodaira, Tokyo, Japan
- Rotterdam, South Holland, Netherlands
- Barcelona, Spain
+ 3 more site(s).
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, 41 years to 81 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Englewood, Colorado, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States; Melbourne, Victoria, Australia; Caen, France and 17 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.