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

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InnoMedica Schweiz AG

Criteria

Inclusion Criteria:

• Informed consent as documented by signature.

• Confirmed Parkinson's disease according to British brain bank criteria.

• Hoehn and Yahr Stage 0 - 2.5 on medication.

• Stable on PD treatment for a month at least.

• Absence of dementia confirmed by cognitive testing (MoCA >25).

Exclusion Criteria:

• Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to class of drugs or the investigational product.

• Women who are pregnant or breast feeding, or planning to become pregnant during the course of the trial or in the 3 months following the trial.

• Lack of safe contraception in women with childbearing potential

• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc) that is not under stable control.

• Subject has an atypical parkinsonian syndrome or secondary parkinsonism.

• Patients with comorbidity that may interfere with the course of the trial.