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Parkinson DiseasePhase 1NEONNCT04976127

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

A Phase 1 study testing Talineuren in people with Parkinson Disease, run by InnoMedica Schweiz AG at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 85 years
Conditions the study is for
Parkinson Disease
What is being tested?
Talineuren
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteSwitzerland
Study dates
11 Dec 2021to 6 Aug 2025
Phase
Phase 1
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 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent as documented by signature.
  • Confirmed Parkinson's disease according to British brain bank criteria.
  • Hoehn and Yahr Stage 0 - 2.5 on medication.
  • Stable on PD treatment for a month at least.
  • Absence of dementia confirmed by cognitive testing (MoCA >25).

Who cannot join

  • Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to class of drugs or the investigational product.
  • Women who are pregnant or breast feeding, or planning to become pregnant during the course of the trial or in the 3 months following the trial.
  • Lack of safe contraception in women with childbearing potential
  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc) that is not under stable control.
  • Subject has an atypical parkinsonian syndrome or secondary parkinsonism.
  • Patients with comorbidity that may interfere with the course of the trial.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Neurologisches Institut Konolfingen

    Konolfingen, Canton of Bern, 3510

Other trials in Switzerland

About this study

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.

Read the detailed description

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).

Being tested
Talineuren
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TalineurenDrug

    Also called liposomal GM1

    Talineuren is a liposomal formulation of the GM1 Ganglioside for intravenous administration

Study groups in NCT04976127
Study groupRoleWhat they receive
Talineuren dose escalationExperimental14 doses of GM1 Ganglioside 6, 12, 60, 120, 180, 240, 300, 360, 420, 480, 540, 600, 660, 720 mg. Optional treatment prolongations for 16 weeks (Amendment 2), 8 months (Amendment 3), 4 months (Amendment 4) and 12 months (Amendment 5).
Receives: Drug: Talineuren
Talineuren repeated doseExperimental8 repeated doses of GM1 Ganglioside tbd from the escalation dose (maximum suitable dose). Optional treatment prolongations for 16 weeks (Amendment 2), 8 months (Amendment 3), 4 months (Amendment 4) and 12 months (Amendment 5).
Receives: Drug: Talineuren
Talineuren dose consolidation with intrapatient dosing (additional patients)Experimental8 months repeated doses of 720mg GM1 Ganglioside (Amendment 3).
Receives: Drug: Talineuren

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurence of adverse events (safety)

    Number and kinds of adverse events (AEs)

    Measured: 8 to 134 weeks

  2. Occurence of serious adverse events (safety)

    Number and kinds of serious adverse events (SAEs)

    Measured: 8 to 134 weeks

  3. Occurence of other safety-related signs (safety)

    Number and kinds of other safety-related signs

    Measured: 8 to 134 weeks

Secondary outcomes (15)

  1. Levodopa challenge (LDC) test

    Assessing the patients' condition via the LDC test (MDS-UPDRS-3 score)

    Measured: 8 to 134 weeks

  2. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Assessing the patients' condition via the test

    Measured: 8 to 134 weeks

  3. Epworth Sleepiness Scale (ESS)

    Assessing the patients' condition via the test

    Measured: 8 to 134 weeks

  4. Parkinson's Disease Questionnaire (PDQ-39)

    Assessing the patients' condition via the test

    Measured: 8 to 134 weeks

  5. Change in Parkinson's medication

    Assessing the patients' condition via the change in their pre-existing Parkinson's medication

    Measured: 8 to 134 weeks

  6. Starkstein Apathy Scale (SAS)

    Assessing the patients' condition via the test

    Measured: 8 to 134 weeks

  7. Montreal Cognitive Assessment (MoCA)

    Assessing the patients' condition via the test

    Measured: 8 to 134 weeks

  8. Beck's Depression Inventory (BDI)

    Assessing the patients' condition via the test

    Measured: 8 to 134 weeks

  9. Non-Motor Symptoms Questionnaire (NMSQuest)

    Assessing the patients' condition via the test

    Measured: 8 to 134 weeks

  10. Maximum Observed Drug Concentration (Cmax) in serum

    Pharmacokinetics (PK) of total GM1 in serum over the first 96 h

    Measured: 8 to 15 weeks

  11. Time of Maximum Drug Concentration (Tmax) in serum

    Pharmacokinetics (PK) of total GM1 in serum over the first 96 h

    Measured: 8 to 15 weeks

  12. Area Under the Curve to infinity (AUCinf.) in serum

    Pharmacokinetics (PK) of total GM1 in serum over the first 96 h

    Measured: 8 to 15 weeks

  13. half-life (t1/2)

    Pharmacokinetics (PK) of total GM1 in serum over the first 96 h

    Measured: 8 to 15 weeks

  14. Clearance (CL)

    Pharmacokinetics (PK) of total GM1 in serum over the first 96 h

    Measured: 8 to 15 weeks

  15. Volume of distribution (Vd)

    Pharmacokinetics (PK) of total GM1 in serum over the first 96 h

    Measured: 8 to 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2021
  2. Study start11 Dec 2021
  3. Primary completion6 Aug 2025
  4. Study completion6 Aug 2025

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

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part 1: dose escalation phase, 3 patients with Parkinson's disease, (2 cohorts as in 1+2 patients, sequential inclusion between the first and 2nd patient) Part 2: repeated dose administration phase, 9 patients with Parkinson's disease (1 cohort) Part 3: Dose consolidation with intrapatient dosing, 10 patients with Parkinson's disease (1 cohort)
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04976127
Sponsor's protocol ID
TLN/PD/1
Acronym
NEON
Status last verified
Sep 2025
First submitted
16 May 2021
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 40359409

  • 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.

    PubMed 37534999

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Talineuren in people with Parkinson Disease, run by InnoMedica Schweiz AG at 1 site in Switzerland.

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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 stopped early (reason given: Treatment stopped earlier due to Verfügung Swissmedic. Safety visits in the end of the trial still were carried out (LPLV 06.08.2025).). Results are not available in the source record.

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?

Occurence of adverse events (safety) (time frame: 8 to 134 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04976127, which also lists 2 linked publications.

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 22 Apr 2026.

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