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NCT04976127: NEON
Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients
Phase 1 trial testing Talineuren in Parkinson Disease in 22 participants. Terminated before completion.
6 August 2025
Quick facts
| Lead sponsor | InnoMedica Schweiz AG |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 11 December 2021 |
| Primary completion | 6 August 2025 |
| Estimated completion | 6 August 2025 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Talineuren — full drug profile →
Conditions studied
- Parkinson Disease — all drugs for Parkinson Disease →
Sponsor
InnoMedica Schweiz AG — full company profile →
Who can join
Adults 30 to 85, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Occurence of adverse events (safety)
Time frame: 8 to 134 weeks
Number and kinds of adverse events (AEs) -
Occurence of serious adverse events (safety)
Time frame: 8 to 134 weeks
Number and kinds of serious adverse events (SAEs) -
Occurence of other safety-related signs (safety)
Time frame: 8 to 134 weeks
Number and kinds of other safety-related signs
Sponsor's own description
This study is an open-label, single ascending dose escalation followed by a multiple administration dose at the maximal suitable dose (MSD). The investigational Medicinal Product (IMP) is given as an add-on therapy. Talineuren consists of GM1 (monosialotetrahexosylganglioside), the pharmacologically active ingredient, associated with a proprietary lipid formulation assembled as liposomes. The primary objective is to demonstrate the safety of TLN administration intravenously in Parkinson patients. Secondary objectives are the determination of the maximal suitable dose based on the safety profile and preliminary efficacy, as well as the determination of the pharmacokinetics (PK) profile.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Recent Advances in Nanotherapeutics for Neurological Disorders.
Vashist A, Manickam P, Raymond AD, Arias AY, et al · · 2023 · cited 33× · PMID 37368486 · DOI 10.1021/acsabm.3c00254 -
Liposomes: An emerging carrier for targeting Alzheimer's and Parkinson's diseases.
Pandian SRK, Vijayakumar KK, Murugesan S, Kunjiappan S. · · 2022 · cited 28× · PMID 35706935 · DOI 10.1016/j.heliyon.2022.e09575 -
An Overview on the Physiopathology of the Blood-Brain Barrier and the Lipid-Based Nanocarriers for Central Nervous System Delivery.
Susa F, Arpicco S, Pirri CF, Limongi T. · · 2024 · cited 15× · PMID 39065547 · DOI 10.3390/pharmaceutics16070849 -
Lipidic Nanoparticles, Extracellular Vesicles and Hybrid Platforms as Advanced Medicinal Products: Future Therapeutic Prospects for Neurodegenerative Diseases.
Tsakiri M, Tsichlis I, Zivko C, Demetzos C, et al · · 2024 · cited 6× · PMID 38543244 · DOI 10.3390/pharmaceutics16030350 -
Safety and tolerability of intravenous liposomal GM1 in patients with Parkinson disease: A single-center open-label clinical phase I trial (NEON trial).
Halbherr S, Lerch S, Bellwald S, Polakova P, et al · · 2025 · cited 5× · PMID 40359409 · DOI 10.1371/journal.pmed.1004472 -
Interactions of alpha-synuclein with membranes in Parkinson's disease: Mechanisms and therapeutic strategies.
Li B, Dettmer U. · · 2024 · cited 5× · PMID 39181187 · DOI 10.1016/j.nbd.2024.106646 -
Engineered GM1 Intersects Between Mitochondrial and Synaptic Pathways to Ameliorate ALS Pathology.
Pilotto F, Toth TD, Bond S, Schmitz A, et al · · 2026 · PMID 41489058 · DOI 10.1002/advs.202514128 -
Nano-structured strategies in combatting neurodegeneration.
Prasanth MI, Mallya AR, Cho WC, Mundekkad D. · · 2025 · PMID 41409624 · DOI 10.3389/fbioe.2025.1638668
Verify or expand the search:
- PubMed search for NCT04976127
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04976127 (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 InnoMedica Schweiz AG
- Last refreshed: 17 April 2026
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/NCT04976127.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing