Estimates of the Short-term Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease
Status:
NOT_YET_RECRUITING
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
This study is double-blinded placebo controlled to estimate the short-term efficacy of Talineuren. The investigational Medicinal Product (IMP) is administrated 18 times intravenously as an add-on therapy to the standard of care Parkinson medication.
Talineuren is a liposomal formulation containing GM1 (monosialotetrahexosylganglioside) as the pharmacological active substance.
The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial.