NCT05152914 is a Phase 1, PHASE2 clinical trial of Cerliponase Alfa in Neuronal Ceroid Lipofuscinosis Type 2, sponsored by David L Rogers, MD.

Who is sponsoring NCT05152914?

NCT05152914 is sponsored by David L Rogers, MD.

What drugs are being tested in NCT05152914?

Interventions in NCT05152914: Cerliponase Alfa.

What condition does NCT05152914 study?

NCT05152914 studies Neuronal Ceroid Lipofuscinosis Type 2.

Is NCT05152914 still recruiting?

NCT05152914 is currently active, enrolled. Last updated 11 June 2025.

Last reviewed 2025-06-11 · How we verify

NCT05152914

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Intravitreal ERT to Prevent Retinal Disease Progression in Children With CLN2

Active, enrolled Phase 1, PHASE2 Last updated 11 June 2025

What this trial tests

Phase 1, PHASE2 trial testing Cerliponase Alfa in Neuronal Ceroid Lipofuscinosis Type 2 in 5 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 November 2021

Primary endpoint
1 November 2025

1 November 2027

Quick facts

Lead sponsor	David L Rogers, MD
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 November 2021
Primary completion	1 November 2025
Estimated completion	1 November 2027
Sites	1 location across United States

Drugs / interventions tested

Cerliponase Alfa (CERLIPONASE ALFA) — full drug profile →

Conditions studied

Neuronal Ceroid Lipofuscinosis Type 2 — all drugs for Neuronal Ceroid Lipofuscinosis Type 2 →

Sponsor

David L Rogers, MD

Who can join

Adults 24 Months to 72 Months, any sex, with Neuronal Ceroid Lipofuscinosis Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase I/II randomized, masked, clinical trial to determine the safety and efficacy of intravitreal administration of cerliponase alfa.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging Perspectives on Gene Therapy Delivery for Neurodegenerative and Neuromuscular Disorders.
Gomez Limia C, Baird M, Schwartz M, Saxena S, et al · · 2022 · cited 13× · PMID 36556200 · DOI 10.3390/jpm12121979
Neuronal Ceroid Lipofuscinosis-Concepts, Classification, and Avenues for Therapy.
Zhang Y, Du B, Zou M, Peng B, et al · · 2025 · cited 7× · PMID 39925015 · DOI 10.1111/cns.70261
Experimental Therapeutic Approaches for the Treatment of Retinal Pathology in Neuronal Ceroid Lipofuscinoses.
Bartsch U, Storch S. · · 2022 · cited 7× · PMID 35509995 · DOI 10.3389/fneur.2022.866983
Natural history of retinal degeneration in ovine models of CLN5 and CLN6 neuronal ceroid lipofuscinoses.
Murray SJ, Mitchell NL. · · 2022 · cited 5× · PMID 35256654 · DOI 10.1038/s41598-022-07612-7
Neuronal ceroid lipofuscinosis: underlying mechanisms and emerging therapeutic targets.
Ziółkowska EA, Takahashi K, Dickson PI, Sardiello M, et al · · 2025 · cited 4× · PMID 40908342 · DOI 10.1038/s41582-025-01132-4
Autosomal Recessive Cerebellar Ataxias: Translating Genes to Therapies.
Fogel BL, Klopstock T, Lynch DR, Maltecca F, et al · · 2025 · cited 2× · PMID 40464291 · DOI 10.1002/ana.27271
Enzyme Replacement Therapy in CLN2-Associated Retinopathy.
Priglinger C, Courage C, Maier EM. · · 2025 · cited 1× · PMID 40127655 · DOI 10.1055/a-2528-7886

Verify or expand the search:

Other trials of Cerliponase Alfa

Trials testing the same drug.

NCT04476862 — Cerliponase Alfa Observational Study in the US · active not recruiting

Other recruiting trials for Neuronal Ceroid Lipofuscinosis Type 2

Currently open trials in the same condition.

NCT05791864 — A First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of Gene Therapy With TTX-381 · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05152914 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by David L Rogers, MD
Last refreshed: 11 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05152914.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing