Safety, Tolerability, and Efficacy of PLX-200 in Patients With CLN3
← catalyst calendarNCT04637282 · readout in 134 d
Sponsored by Polaryx Therapeutics, Inc. (industry) · PLYX — their whole pipeline →.
Phase
Phase 3
Status
Withdrawn
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
0actual
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Study has yet to begin and removing to avoid further participant outreach to sponsor
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-11-01 | estimated | When the study began enrolling |
| Primary completion | 2026-12-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2020-11-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Juvenile Neuronal Ceroid Lipofuscinosis
Interventions
- Drug: PLX-200 — also filed as Gemfibrozil
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFEfficacy of PLX-200 in CLN3 as assessed by the change in the motor score of the Hamburg Rating Scale compared with that of the Placebo group
measured 60 weeks
Number of patients with treatment-related adverse events, as assessed by CTCAE v5.0, abnormal laboratory results, and abnormal cardiovascular and/or abdominal findings.
measured 96 weeks
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