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TERMINATED
NCT04976127
PHASE1

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

Sponsor: InnoMedica Schweiz AG

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

30 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2021-12-11

Completion Date

2025-08-06

Last Updated

2026-04-22

Healthy Volunteers

No

Interventions

DRUG

Talineuren

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

Locations (1)

Neurologisches Institut Konolfingen

Konolfingen, Canton of Bern, Switzerland