Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients (NEON)
Sponsor: InnoMedica Schweiz AG
Terminated
Treatment stopped earlier due to Verfügung Swissmedic. Safety visits in the end of the trial still were carried out (LPLV 06.08.2025).
Other Parkinson Disease trials with similar outcome
This observational or N/A phase trial investigates Parkinson Disease and is currently terminated or withdrawn. InnoMedica Schweiz AG leads this study, which shows 9 recorded versions since 2021 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)The ganglioside lipid GM1 has been described in the literature as a neuroprotective agent. Several clinical studies have shown that GM1 improves the condition of Parkinson's disease patients. Talineuren consists of the pharmacologically active ingredient GM1, associated with a proprietary lipid formulation assembled as liposomes. Talineuren has been developed to improve the delivery and bioavailability of GM1. The primary objective of this trial is to demonstrate the feasibility and safety of intravenous Talineuren administration in Parkinson's disease patients. The secondary objectives are: * The determination of the recommended phase 2 dose based on the safety profile and preliminary efficacy. * The determination of the pharmacokinetics (PK) profile. This trial aims to investigate the safety of the novel formulation of GM1, Talineuren. To that extent a three-part trial was designed: Part 1- Dose escalation Part 2- Dose consolidation Part 3- Dose consolidation with intrapatient dosing Part 1- rapid dose escalation scheme from 6 mg to 720 mg of Talineuren formulated GM1 in 3 patients. Optional treatment prolongations for 8 weeks (Amendment 1), 16 weeks (Amendment 2), 8 months (Amendment 3), 4 months (Amendment 4), and 12 months (Amendment 5). Part 2- multiple dosing of Talineuren over 8 weeks in 9 patients...
The ganglioside lipid GM1 has been described in the literature as a neuroprotective agent.
Several clinical studies have shown that GM1 improves the condition of Parkinson's disease patients.
Talineuren consists of the pharmacologically active ingredient GM1, associated with a proprietary lipid formulation assembled as liposomes. Talineuren has been developed to improve the delivery and bioavailability of GM1.
The primary objective of this trial is to demonstrate the feasibility and safety of intravenous Talineuren administration in Parkinson's disease patients.
The secondary objectives are:
* The determination of the recommended phase 2 dose based on the safety profile and preliminary efficacy. * The determination of the pharmacokinetics (PK) profile.
This trial aims to investigate the safety of the novel formulation of GM1, Talineuren.
To that extent a three-part trial was designed: Part 1- Dose escalation Part 2- Dose consolidation Part 3- Dose consolidation with intrapatient dosing
Part 1- rapid dose escalation scheme from 6 mg to 720 mg of Talineuren formulated GM1 in 3 patients. Optional treatment prolongations for 8 weeks (Amendment 1), 16 weeks (Amendment 2), 8 months (Amendment 3), 4 months (Amendment 4), and 12 months (Amendment 5).
Part 2- multiple dosing of Talineuren over 8 weeks in 9 patients to validate the safety profile of the maximum suitable dose. Optional treatment prolongations for 16 weeks (Amendment 2), 8 months (Amendment 3), 4 months (Amendment 4), and 12 months (Amendment 5).
Part 3- rapid dose escalation scheme from 6 mg to 720 mg of Talineuren followed by multiple doses of 720mg Talineuren for up to 8 months in 10 patients (Amendment 3). Additional Follow-up visit (washout timepoint) 4 months after final assessment (Amendment 6).
Status Flow
Change History
9 versions recorded-
Apr 23, 2026 — Present [daily]
Terminated
Status: Active Not Recruiting → Terminated · Phase: PHASE1 → None
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Sep 2024 — Apr 2026 [monthly]
Active Not Recruiting PHASE1
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE1
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Apr 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE1
-
Dec 2023 — Apr 2024 [monthly]
Active Not Recruiting PHASE1
Status: Recruiting → Active Not Recruiting
▶ Show 4 earlier versions
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Apr 2023 — Dec 2023 [monthly]
Recruiting PHASE1
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Jan 2022 — Apr 2023 [monthly]
Recruiting PHASE1
Status: Not Yet Recruiting → Recruiting
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Dec 2021 — Jan 2022 [monthly]
Not Yet Recruiting PHASE1
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Sep 2021 — Dec 2021 [monthly]
Not Yet Recruiting PHASE1
First recorded
Eligibility 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.
Contact Information
- InnoMedica Schweiz AG
For direct contact, visit the study record on ClinicalTrials.gov .