Juvenile Neuronal Ceroid LipofuscinosisPhase 3NCT04637282
Safety, Tolerability, and Efficacy of PLX-200 in Patients With CLN3
A Phase 3 study testing PLX-200 in people with Juvenile Neuronal Ceroid Lipofuscinosis, run by Polaryx Therapeutics, Inc..
Trial summary
The purpose of this study is to evaluate the safety and efficacy of multiple doses of PLX-200 in patients with CLN3 disease. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Juvenile Neuronal Ceroid Lipofuscinosis
- What is being tested?
- PLX-200
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female participants between the ages of 6 and 18 years of age. Any deviations from this age range must be approved by the Medical Monitor and Sponsor prior to entry into study.
- Has a diagnosis of "classic" CLN3 disease as determined by age of symptom onset (i.e., 4 to 7 years) and genetic analysis for a defect in the CLN3 (battenin) transmembrane gene at study entry. If no genotype information is available, blood will be collected for the CLN3 gene analysis at the Screening visit.
- Participant must have mild-to-moderate CLN3 disease documented by a total in the 3-domain score of 5 to 7 for the aggregate of the motor, language, and vision domains of the Hamburg Scale and a score of at least 2 in 2 of these 3 domains.
- Participant must be able to independently walk for a distance of at least 20 feet (6 meters).
- Participant must be able to tolerate swallowing oral medication.
- Participants who are of childbearing potential (i.e., have begun menstruation) must have a negative serum pregnancy test at Baseline before receiving PLX-200. Nursing mothers are excluded from participation in this study.
- Participants' parents/guardians must agree to comply in good faith with the conditions of the study, including attending all required baseline and follow-up assessments.
- Participant parents and legal guardians must sign the informed consent form, and participants will provide assent, depending on local regulations and developmental status.
Who cannot join
- Participant has asymptomatic CLN3 disease, defined as no evidence of neurological signs or symptoms attributed to CLN3 disease such as seizures, ataxia, language delay, or other developmental delays. Similarly, outliers who progress much more slowly or quickly compared to the rest of the study population will be excluded from study at the discretion of the PI in consultation with the Medical Monitor (e.g., c.1A > C start codon mutation).
- Participant has clinically documented generalized motor status epilepticus within 4 weeks of the Baseline visit (treatment may be postponed after discussion with the Medical Monitor until seizures are adequately controlled).
- Participant has another inherited neurologic disease in addition to CLN3 disease.
- Participant has another neurological illness that may cause cognitive or motor decline.
- Participants with enteral feeding with NG tubing and any difficulty in oral administration and/or absorption of study drug will be excluded.
- Participant requires ventilation support, except for noninvasive support at night (e.g., Continuous Positive Airway Pressure [CPAP], Bilevel Positive Airway Pressure [BiPAP]).
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- Participant has moderate or severe hepatic dysfunction defined as alanine aminotransferase, aspartate aminotransferase, or total bilirubin >3x upper limit of normal (ULN) except for participants with Gilbert syndrome. Participant has primary biliary cirrhosis.
- Participant has anemia (defined as hemoglobin <10 g/dL or hematocrit <30%).
- Participant has a baseline serum creatinine >2 mg/dL.
- Participant has gallbladder disease (e.g., cholelithiasis or cholecystitis).
- Participant has hypersensitivity to gemfibrozil.
- Participant is using or requires treatment with 1. HMG-CoA reductase inhibitors, 2. repaglinide (Prandin®), 3. dasabuvir (Exviera®), 4. selexipag (Uptravi®), or 5. pioglitazone (Actos®).
- Since the participant may take anticoagulants, increased frequency of INR monitoring is essential to avoid potential toxic effects with concurrent PLX-200 and anticoagulants (in particular with warfarin).
- Participant has a medical condition or personal circumstance that, in the opinion of the Investigator, might compromise the participant's or parent/guardian's ability to comply with the protocol requirements, or compromise the participant's wellbeing, safety, or the interpretability of the study data.
- Participant has received any investigational product or medical device within 30 days of the Baseline visit that, in the Investigator's judgment, would make the participant ineligible or confound results. All subjects who have had an investigational product or products in the form of stem cell or gene therapy are excluded, regardless of when the therapy had been initiated and/or discontinued.
About this study
Official title: A Randomized. Multicenter, Double-Blind, Placebo-Controlled Safety, Tolerability, and Efficacy Study of PLX-200 in Participants With Mild-to-Moderate Juvenile Neuronal Ceroid Lipofuscinosis (CLN3) Disease
The purpose of this study is to evaluate the safety and efficacy of multiple doses of PLX-200 in patients with CLN3 disease.
Read the detailed description
This is a phase 3, double-blind, placebo-controlled, dose-titration study to evaluate escalating weight-based dose levels of PLX-200, provided as a solution that contains 15 mg/mL PLX-200 and administered orally using a syringe, as needed, twice daily (BID), 30 minutes before breakfast and dinner. Participants will enter the Titration Period, during which the starting dose of PLX-200 or placebo will be based on patient weight. Each patient's dose will be titrated upward on a weekly basis during the Titration Period, until he or she reaches a maximally tolerated dose (MTD) or the Week 5 dose for their weight category. The patient will then enter the Maintenance Period at the final Titration Period dose for a maximum of 60 weeks. Safety, efficacy, and pharmacokinetics will be assessed periodically. Thereafter, all patients will have the opportunity to receive active treatment in an Open-Label Extension (OLE) for an additional 36 weeks.
- Conditions
- Juvenile Neuronal Ceroid Lipofuscinosis
- Being tested
- PLX-200, Placebo
- Keywords
- CLN3, Batten disease, Children
- Medical subject headings
- Neuronal Ceroid-Lipofuscinoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLX-200Drug
Also called Gemfibrozil
15 mg/mL oral solution of experimental drug
PlaceboDrug
Taste and color-matched drug-free solution
| Study group | Role | What they receive |
|---|---|---|
| PLX-200 | Experimental | This is randomized, placebo-controlled comparator study of PLX-200 in patients with CLN3 disease. Receives: Drug: PLX-200 |
| Placebo | Placebo comparator | This is randomized comparator study of PLX-200 vs. placebo in a 2:1 ratio in patients with CLN3 disease. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy 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
The change from baseline in the motor score of the Hamburg Rating Scale at Week 60 of maintenance therapy in participants treated with PLX-200 compared with that of Placebo group. Baseline is defined as the motor score of the Hamburg Rating Scale assessment prior to starting drug or Placebo group in the Titration Period. The Hamburg Rating Scale records a rating of 0 - 3 in four domains: motor skills, vision, language, and seizures, all from 0 - 3 which is worse to normal, respectively, with a minimum (worse) score of 0 to a maximum (normal) score of 12.
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.
The aggregate of clinical chemistries, hematology, urinalysis, electrocardiogram readings, abdominal ultrasound findings, and tabulation of the number and severity of adverse events will be compared with baseline values throughout the study to evaluate the safety and tolerability of PLX-200 at escalating oral doses in children with CLN3 disease.
Measured: 96 weeks
Secondary outcomes (9)
Efficacy of PLX in each of the domains of the Hamburg Scale
Changes in the Baseline score of each of the 4 domains of the Hamburg Rating Scale (motor, language, visual, and seizures) at 24, 48, 60 (except motor score), 72, and 96 weeks of maintenance therapy in those treated with PLX-200 compared with those treated with Placebo. The Hamburg rating per domain is 0 - 3 with 3 representing worse outcomes.
Measured: 24, 48, 60, 72 and 96 weeks
Assessment of the overall decline status in subjects treated with PLX-200 compared with the placebo group
The overall decline status (Yes/No) at Maintenance Weeks 60 and 96 in subjects treated with PLX-200 compared to those treated with Placebo. A subject will be considered to have an overall decline if either (i) a decrease from baseline in any of the 4 domains (motor, language, visual, seizure) of the Hamburg rating scale is observed or (ii) the assessment is missing at the visit for any reason. The Hamburg rating per domain is 0 - 3 with 3 representing worse outcomes.
Measured: 60 and 96 weeks
Evaluation of the baseline motor score decline between PLX-200 and placebo
The Motor Score decline status (Yes/No) at Maintenance Weeks 60 and 96 in subjects treated with PLX-200 compared to those treated with Placebo using two alternative definitions. In Definition 1, a subject will be considered to have declined (i.e. worsened) if at least a one-point decrease from baseline in the motor score of the Hamburg scale is observed or if the visit is missing for any reason. In Definition 2, subjects with at least a 2-point decrease or if the visit is missing will be considered to have declined.
Measured: 60 and 96 weeks
Assessment of changes in the baseline Clinical Impression of symptom severity between PLX-200 and Placebo groups
Changes from baseline in the Clinical Global Impression of symptom severity to 24, 48, 60, 72, and 96 weeks of maintenance therapy in those treated with PLX-200 compared with those treated with Placebo. The CGI severity scale (CGI-S) rates illness severity and the CGI-Improvement (CGI-I) which both rate on a scale of 1 - 7 which relates to improved/very much improved to worse disease.
Measured: 24, 48, 60, 72, and 96 weeks
Assessment of changes in the baseline Pediatric Balance Scale between PLX-200 and Placebo groups
Change in the Pediatric Balance Scale (modified Berg Balance Scale) score from Baseline to 24, 48, 60, 72, and 96 weeks of maintenance therapy in those treated with PLX-200 compared with those treated with Placebo. The scale is age, weight, height, and gender specific but across all groups, the higher score between 0 - 4 represents better outcomes than 0 which is worse outcome.
Measured: 24, 48, 60, 72, and 96 weeks
Assessment of changes in the baseline Montreal Assessment Cognitive Scale between PLX-200 and Placebo groups
Change in the Montreal Cognitive Assessment (MoCA) score from Baseline to 24, 48, 60, 72, and 96 weeks of maintenance therapy in those treated with PLX-200 compared with those treated with Placebo. The MoCA cutoff score of 26 differentiates youth with and without cognitive impairment with the lower score being considered increased cognitive impairment.
Measured: 24, 48, 60, 72, and 96 weeks
Assessment of changes in the baseline Vineland Behavior Scale between PLX-200 and Placebo groups
Change in the Vineland Behavior Scale from Baseline to 24, 48, 60, 72, and 96 weeks of maintenance therapy in those treated with PLX-200 compared with those treated with Placebo. The Vineland Scale captures changes in intellectual and developmental disabilities. To date, there are no normal values determined for the Vineland Behavior Scale but the higher the score suggests greater capabilities.
Measured: 24, 48, 60, 72, and 96 weeks
Assessment of changes in the baseline walking ability of the patient between PLX-200 and Placebo groups
Change in walking ability (6-minute walk test; 6MWT) from Baseline to weeks 24, 48, 60, 72, and 96 weeks of maintenance therapy in those treated with PLX-200 compared with those treated with Placebo. The 6MWT normal range is highly specific to the patient. Thus, all tests will be compared to the Baseline value during the Screening Phase.
Measured: 24, 48, 60, 72, and 96 weeks
PLX-200 pharmacokinetics (PK) will be evaluated through periodic blood draws during the trial. PLX-200 levels will be determined to estimate area under the curve, maximal concentration, time to maximal concentration, half-life, and dosing interval
To evaluate PLX-200 plasma concentrations in blood collected from participants during the Titration and Maintenance Periods for PK analyses, namely Cmax (maximal PLX-200 concentration) and Tmax (time to Cmax), elimination half-life (t1/2), area under the plasma concentration-time curve (AUC), and the dosing interval.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Study has yet to begin and removing to avoid further participant outreach to sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Neuronal Ceroid LipofuscinosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, within-subject, dose-titration design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polaryx Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637282
- Sponsor's protocol ID
- PLX-200-002
- Status last verified
- Jul 2026
- First submitted
- 4 Nov 2020
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: None planned.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized. Multicenter, Double-Blind, Placebo-Controlled Safety, Tolerability, and Efficacy Study of PLX-200 in Participants With Mild-to-Moderate Juvenile Neuronal Ceroid Lipofuscinosis (CLN3) Disease
- ClinicalTrials.gov ID
- NCT04637282
- Acronym / sponsor ID
- PLX-200-002
- Conditions
- Juvenile Neuronal Ceroid Lipofuscinosis
- Keywords
- CLN3, Batten disease, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has yet to begin and removing to avoid further participant outreach to sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Polaryx Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of multiple doses of PLX-200 in patients with CLN3 disease.
Detailed description
This is a phase 3, double-blind, placebo-controlled, dose-titration study to evaluate escalating weight-based dose levels of PLX-200, provided as a solution that contains 15 mg/mL PLX-200 and administered orally using a syringe, as needed, twice daily (BID), 30 minutes before breakfast and dinner. Participants will enter the Titration Period, during which the starting dose of PLX-200 or placebo will be based on patient weight. Each patient's dose will be titrated upward on a weekly basis during the Titration Period, until he or she reaches a maximally tolerated dose (MTD) or the Week 5 dose for their weight category. The patient will then enter the Maintenance Period at the final Titration Period dose for a maximum of 60 weeks. Safety, efficacy, and pharmacokinetics will be assessed periodically. Thereafter, all patients will have the opportunity to receive active treatment in an Open-Label Extension (OLE) for an additional 36 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, within-subject, dose-titration design
| Arm | Type | Receives |
|---|---|---|
| PLX-200 | Experimental | Drug: PLX-200This is randomized, placebo-controlled comparator study of PLX-200 in patients with CLN3 disease. |
| Placebo | Placebo comparator | Drug: PlaceboThis is randomized comparator study of PLX-200 vs. placebo in a 2:1 ratio in patients with CLN3 disease. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Male and female participants between the ages of 6 and 18 years of age. Any deviations from this age range must be approved by the Medical Monitor and Sponsor prior to entry into study.
- Has a diagnosis of "classic" CLN3 disease as determined by age of symptom onset (i.e., 4 to 7 years) and genetic analysis for a defect in the CLN3 (battenin) transmembrane gene at study entry. If no genotype information is available, blood will be collected for the CLN3 gene analysis at the Screening visit.
- Participant must have mild-to-moderate CLN3 disease documented by a total in the 3-domain score of 5 to 7 for the aggregate of the motor, language, and vision domains of the Hamburg Scale and a score of at least 2 in 2 of these 3 domains.
- Participant must be able to independently walk for a distance of at least 20 feet (6 meters).
- Participant must be able to tolerate swallowing oral medication.
Key exclusion criteria (15 listed)
- Participant has asymptomatic CLN3 disease, defined as no evidence of neurological signs or symptoms attributed to CLN3 disease such as seizures, ataxia, language delay, or other developmental delays. Similarly, outliers who progress much more slowly or quickly compared to the rest of the study population will be excluded from study at the discretion of the PI in consultation with the Medical Monitor (e.g., c.1A > C start codon mutation).
- Participant has clinically documented generalized motor status epilepticus within 4 weeks of the Baseline visit (treatment may be postponed after discussion with the Medical Monitor until seizures are adequately controlled).
- Participant has another inherited neurologic disease in addition to CLN3 disease.
- Participant has another neurological illness that may cause cognitive or motor decline.
- Participants with enteral feeding with NG tubing and any difficulty in oral administration and/or absorption of study drug will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLX-200Also: Gemfibrozil15 mg/mL oral solution of experimental drug | Drug | PLX-200 |
| PlaceboTaste and color-matched drug-free solution | Drug | Placebo |
Primary outcome
Efficacy 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
Time frame: 60 weeks
The change from baseline in the motor score of the Hamburg Rating Scale at Week 60 of maintenance therapy in participants treated with PLX-200 compared with that of Placebo group. Baseline is defined as the motor score of the Hamburg Rating Scale assessment prior to starting drug or Placebo group in the Titration Period. The Hamburg Rating Scale records a rating of 0 - 3 in four domains: motor skills, vision, language, and seizures, all from 0 - 3 which is worse to normal, respectively, with a minimum (worse) score of 0 to a maximum (normal) score of 12.
Number of patients with treatment-related adverse events, as assessed by CTCAE v5.0, abnormal laboratory results, and abnormal cardiovascular and/or abdominal findings.
Time frame: 96 weeks
The aggregate of clinical chemistries, hematology, urinalysis, electrocardiogram readings, abdominal ultrasound findings, and tabulation of the number and severity of adverse events will be compared with baseline values throughout the study to evaluate the safety and tolerability of PLX-200 at escalating oral doses in children with CLN3 disease.
9 secondary outcomes
Efficacy of PLX in each of the domains of the Hamburg Scale
Time frame: 24, 48, 60, 72 and 96 weeks
Assessment of the overall decline status in subjects treated with PLX-200 compared with the placebo group
Time frame: 60 and 96 weeks
Evaluation of the baseline motor score decline between PLX-200 and placebo
Time frame: 60 and 96 weeks
Assessment of changes in the baseline Clinical Impression of symptom severity between PLX-200 and Placebo groups
Time frame: 24, 48, 60, 72, and 96 weeks
Assessment of changes in the baseline Pediatric Balance Scale between PLX-200 and Placebo groups
Time frame: 24, 48, 60, 72, and 96 weeks
Assessment of changes in the baseline Montreal Assessment Cognitive Scale between PLX-200 and Placebo groups
Time frame: 24, 48, 60, 72, and 96 weeks
Assessment of changes in the baseline Vineland Behavior Scale between PLX-200 and Placebo groups
Time frame: 24, 48, 60, 72, and 96 weeks
Assessment of changes in the baseline walking ability of the patient between PLX-200 and Placebo groups
Time frame: 24, 48, 60, 72, and 96 weeks
PLX-200 pharmacokinetics (PK) will be evaluated through periodic blood draws during the trial. PLX-200 levels will be determined to estimate area under the curve, maximal concentration, time to maximal concentration, half-life, and dosing interval
Time frame: 96 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. None planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PLX-200 in people with Juvenile Neuronal Ceroid Lipofuscinosis, run by Polaryx Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy 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 (time frame: 60 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.