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Estimates of the Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease
Sponsor: InnoMedica Schweiz AG
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
Conditions
Interventions
Talineuren
Talineuren infusion weekly
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