A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP) (NCT04993768) | Clinical Trial Compass
CompletedPhase 2
A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP)
United States42 participantsStarted 2021-12-12
Plain-language summary
This is a Phase 2a study to assess the safety and tolerability of TPN-101 patients with PSP.
Who can participate
Age range
41 Years – 86 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Clinical diagnosis of probable progressive supranuclear palsy (PSP)
. Presence of PSP symptoms for less than 5 years
. Has a reliable caregiver/informant to accompany the patient to all study visits.
. Score ≥ 18 on the Mini Mental State Exam (MMSE) at Screening
. Patient must reside outside a skilled nursing facility or dementia care facility at the time of Screening, and admission to such a facility must not be planned. Residence in an assisted living facility is allowed
Exclusion criteria
. Presence of other significant neurological or psychiatric disorders
. History of clinically significant brain abnormality
. Presence of cerebellar ataxia, choreoathetosis, early symptomatic autonomic dysfunction, or moderate to severe resting tremor, responsive to levodopa
. Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean
. Known presence of disease-associated mutation in TARDBP, GRN, CHMPB2, or VCP genes; or any other frontotemporal lobar degeneration causative genes not associated with underlying tau pathology
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this Phase 2a trial of TPN-101 for PSP has already been completed, can you tell me if the safety and tolerability results have been published or shared anywhere, and what they showed?
2This study was specifically designed to test whether TPN-101 is safe and tolerable in PSP patients rather than to prove it works — so what does that mean for understanding the actual benefit to someone with my diagnosis at this stage?
3Given that this trial is now completed and I wasn't part of it, are there any follow-on studies or expanded access programs for TPN-101 that might be worth looking into for my situation?
4PSP is a condition that can progress quickly — based on what you know about this trial's findings, do you think pursuing an experimental treatment like TPN-101 makes more sense for me right now than focusing on currently available standard-of-care options?
5Are there other completed or ongoing clinical trials for PSP that you'd want me to consider alongside this one, especially any that have moved into a later phase with more data on effectiveness?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess the safety and tolerability of TPN-101 in patients with progressive supranuclear palsy (PSP)