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Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients
Sponsor: InnoMedica Schweiz AG
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
Conditions
Interventions
Talineuren
Talineuren is a liposomal formulation of the GM1 Ganglioside for intravenous administration
Locations (1)
Neurologisches Institut Konolfingen
Konolfingen, Canton of Bern, Switzerland