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NOT YET RECRUITING
NCT06431971
PHASE2

Estimates of the Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease

Sponsor: InnoMedica Schweiz AG

View on ClinicalTrials.gov

Summary

This study is double-blinded placebo controlled followed by an open-label extension placebo-to-active switch to estimate the efficacy of Talineuren. The investigational Medicinal Product (IMP) is administrated 48 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.

Official title: Estimates of the Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease: A Randomized, Placebo-controlled, Double-blinded, Parallel 2-arm, With Open-label Extension Placebo-to-active Switch, Multi-centre Phase I/IIa Trial

Key Details

Gender

All

Age Range

30 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2027-01

Completion Date

2028-07

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

DRUG

Talineuren

Talineuren infusion weekly

DRUG

Placebo

Placebo infusion weekly

Locations (6)

Kantonsspital Aarau (KSA), Neurologische Klinik

Aarau, Canton of Aargau, Switzerland

Hôpitaux Universitaires de Genève (HUG), Département des Neurosciences cliniques NEUCLI, Service de Neurologie

Geneva, Canton of Geneva, Switzerland

Health Ostschweiz/ Kantonsspital St. Gallen (KSSG), Klinik für Neurologie

Sankt Gallen, Canton of St. Gallen, Switzerland

Centre hospitalier universitaire Vaudois (CHUV), Clinical Neurosciences Department

Lausanne, Canton of Vaud, Switzerland

Bellevue Medical Group AG (BMG), Neurozentrum Seefeld

Zurich, Canton of Zurich, Switzerland

Neurologisches Institut Konolfingen

Konolfingen, Switzerland