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PROSPER: clinical Phase 2 study to test how safe and effective is a new medicine called FNP-223 to slow disease progression of progressive supranuclear palsy (PSP)
EU CTIS ID: 2023-510366-28-00
What this study is testing
1. To assess the efficacy of FNP-223 in slowing disease progression in participants with PSP as measured by the PSP Rating Scale (PSPRS) over 52 weeks. 2. To assess the safety and tolerability of FNP-223 for 52 weeks in participants with PSP.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Able to understand and willing to provide informed consent prior to entry into the study and able to comply with the study procedures and restrictions.
- Has a caregiver or study partner who will accompany them to the study visits. The caregiver or study partner must be a person who has frequent contact (at least 7 hours per week at 1 time or in different days) with the participant and is able to provide information about the participant`s medication and overall condition. Prior to the conduct of any study procedures, the caregiver or study partner must be willing to sign the independent ethics committee (IEC)/institutional review board (IRB) approved informed consent.
- Women of childbearing potential (WOCBP) (Appendix 19.2) or fertile males with partners of childbearing potential must agree to use highly effective contraception (per CTFG 2014) from enrollment (signed consent) through 30 days after the last dose of the IP.
- Male or female participants aged 50 to 80 years, inclusive, at the time of informed consent.
- Diagnosis of possible or probable PSP-RS phenotypes according to the MDS PSP clinical features criteria (Höglinger et al 2017). At least 1 (either 1 or both) of the following 2 items must be met: 1. Vertical supranuclear gaze palsy. 2. Slowing of vertical saccades AND postural instability with falls within the first 3 years of PSP symptoms.
- Presence of PSP symptoms within ≤3 years prior to screening.
You likely can't join if
- Score of 3 on any functional domain in the PSP-CDS.
- Active chronic inflammatory disease (ie, rheumatoid arthritis, systemic lupus, erythematosus, Crohn’s disease, etc.) which requires chronic treatment not allowed in the study.
- Participant has significant current suicidal ideation or within 1 year prior to screening as evidenced by answering “yes” to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at screening or a history of suicidal attempts within the last 2 years.
- Current diagnosis or history of drug or alcohol abuse (according to DSM-5 criteria) within the last 2 years prior to screening visit.
- Any condition that in the judgment of the investigator would interfere with the ability to complete the study (including IP intake), pose significant risk to participant safety, or potentially confound interpretation of study results.
- Presence of renal impairment as indicated by a creatinine clearance of less than 50 mL/min at screening.
See the full eligibility criteria
Who can join
- Able to understand and willing to provide informed consent prior to entry into the study and able to comply with the study procedures and restrictions.
- Has a caregiver or study partner who will accompany them to the study visits. The caregiver or study partner must be a person who has frequent contact (at least 7 hours per week at 1 time or in different days) with the participant and is able to provide information about the participant`s medication and overall condition. Prior to the conduct of any study procedures, the caregiver or study partner must be willing to sign the independent ethics committee (IEC)/institutional review board (IRB) approved informed consent.
- Women of childbearing potential (WOCBP) (Appendix 19.2) or fertile males with partners of childbearing potential must agree to use highly effective contraception (per CTFG 2014) from enrollment (signed consent) through 30 days after the last dose of the IP.
- Male or female participants aged 50 to 80 years, inclusive, at the time of informed consent.
- Diagnosis of possible or probable PSP-RS phenotypes according to the MDS PSP clinical features criteria (Höglinger et al 2017). At least 1 (either 1 or both) of the following 2 items must be met: 1. Vertical supranuclear gaze palsy. 2. Slowing of vertical saccades AND postural instability with falls within the first 3 years of PSP symptoms.
- Presence of PSP symptoms within ≤3 years prior to screening.
- Full 28-item PSPRS score ≤40.
- Able to ambulate independently or with minimal assistance defined as the ability to take at least 10 steps (stabilization of 1 arm [ie, use of cane]).
- MoCA score ≥23.
- Body weight range ≥43 kg/95 lbs to ≤120 kg/265 lbs.
- Reside outside a skilled nursing facility or dementia care facility, except for participants residing in an assisted living facility.
What rules you out
- Score of 3 on any functional domain in the PSP-CDS.
- Active chronic inflammatory disease (ie, rheumatoid arthritis, systemic lupus, erythematosus, Crohn’s disease, etc.) which requires chronic treatment not allowed in the study.
- Participant has significant current suicidal ideation or within 1 year prior to screening as evidenced by answering “yes” to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at screening or a history of suicidal attempts within the last 2 years.
- Current diagnosis or history of drug or alcohol abuse (according to DSM-5 criteria) within the last 2 years prior to screening visit.
- Any condition that in the judgment of the investigator would interfere with the ability to complete the study (including IP intake), pose significant risk to participant safety, or potentially confound interpretation of study results.
- Presence of renal impairment as indicated by a creatinine clearance of less than 50 mL/min at screening.
- Presence of clinically significant hepatic disease; hepatitis or biliary tract disease as indicated by alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels ≥3×upper limit of normal (ULN), bilirubin levels ≥2×ULN at screening, in the absence of Gilbert’s Syndrome. In the event elevated bilirubin levels are suspected to be due to Gilbert’s Syndrome, exclusion decision will be taken in consultation with the medical monitor. The ultimate decision to exclude the participant will be made by the investigator.
- History of sensitivity to excipients.
- Participants with known PSP genetic mutation (based on familiar or clinical history).
- Evidence of other neurological disorder that could explain signs of PSP (eg, Parkinson's disease, Alzheimer disease, etc.).
- Brain MRI within 1 year of screening consistent with: a. Primary degenerative diseases other than PSP. b.Cerebrovascular disease such as prior hemorrhage or infarct larger than 1 cm; major, strategic, or multiple lacunar infarcts; or extensive white matter lesions scoring 3 in the Wahlund scale (Wahlund et al 2001). Ischemic or hemorrhagic lesions in the substantia nigra, nigrostriatal pathway, brainstem and the basal ganglia would be strategic and would be exclusionary. Other lacunar infarcts will not be considered exclusionary.
- Diagnosis of any of the following psychiatric disorders: schizophrenia, schizoaffective disorder, bipolar disorder I, or alcohol abuse or dependence per Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) criteria.
- Diagnosis of epilepsy.
- Ongoing infectious, metabolic, or systemic diseases affecting the CNS (ie, syphilis, untreated hypothyroidism, current vitamin B12 or folate deficiency, potentially clinically significant serum electrolyte disturbances, unstable diabetes mellitus, or other similar conditions, including history of human immunodeficiency virus.
- Significant (ongoing or within 1 year of screening) cardiovascular disease (ie, medical history of stroke, acute coronary syndrome, heart infarction, unstable angina, angina pectoris, ST segment elevation myocardial infarction (STEMI), non-STEMI, transient ischemic attacks, heart failure (New York Heart Association class III or IV), peripheral vascular intervention, atrial fibrillation, clinically relevant cardiac arrhythmias, or uncontrolled hypertension), or at risk of stroke or heart attack.
- Blood pressure or ECG parameters at screening: a. Seated systolic blood pressure <90 mmHg or >150 mmHg; or diastolic blood pressure <50 mmHg or >90 mmHg. b. ECG abnormalities including: clinically significant conduction abnormalities, ischemic changes (ie, prior Q-wave myocardial infarction and/or marked ischemic ST- and T-wave), arrhythmias (eg, persistent or paroxysmal ventricular or supraventricular arrhythmias, including atrial fibrillation), or other ECG abnormalities that would pose unnecessary risk in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. 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 EU CTIS; the study team decides eligibility.