Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients

Summary

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.

Timeline

Start

2021-12-11

Primary completion

2025-08-06

Completion

2025-08-06

Outcome

Outcome not reported

Stopped: “Treatment stopped earlier due to Verfügung Swissmedic. Safety visits in the end of the trial still were carried out (LPLV 06.08.2025).”

Publications

• Halbherr S, Lerch S, Bellwald S, Polakova P, Bannert B, Roumet M, Charles RP, Walter MA, Bernasconi C, Halbherr VL, Peitsch C, Baumgartner PC, Kaufmann C, Aires V, Mattle HP, Kaelin-Lang A, Hartmann A, Schuepbach M. Safety and tolerability of intravenous liposomal GM1 in patients with Parkinson disease: A single-center open-label clinical phase I trial (NEON trial). PLoS Med. 2025 May 13;22(5):e1004472. doi: 10.1371/journal.pmed.1004472. eCollection 2025 May.
• Roy R, Paul R, Bhattacharya P, Borah A. Combating Dopaminergic Neurodegeneration in Parkinson's Disease through Nanovesicle Technology. ACS Chem Neurosci. 2023 Aug 16;14(16):2830-2848. doi: 10.1021/acschemneuro.3c00070. Epub 2023 Aug 3.

Drugs

Indications