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

NCT04976127 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

DRUG

Talineuren

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

Sponsors & Collaborators

  • InnoMedica Schweiz AG

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-11
Primary Completion
2025-08-06
Completion
2025-08-06

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04976127 on ClinicalTrials.gov