Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients
Key facts
- Who runs it
- InnoMedica Schweiz AG
- Where
- Switzerland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 1
- People taking part
- 22 people enrolled
- Started
- 11 Dec 2021
- Ended
- 6 Aug 2025
- Type of study
- Interventional, 3 groups
- Treatments tested
- Talineuren
- Record updated
- 22 April 2026
- Why it stopped
- Treatment stopped earlier due to Verfügung Swissmedic. Safety visits in the end of the trial still were carried out (LPLV 06.08.2025).
Who can take part
- Age
- 30 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to class of drugs or the investigational product
- 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
- 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
- Patients with comorbidity that may interfere with the course of the trial
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- Talineuren dose escalationTreatment being tested
14 doses of GM1 Ganglioside 6, 12, 60, 120, 180, 240, 300, 360, 420, 480, 540, 600, 660, 720 mg. Optional treatment prolongations for 16 weeks (Amendment 2), 8 months (Amendment 3), 4 months (Amendment 4) and 12 months (Amendment 5).
Treatment: Talineuren
- Talineuren repeated doseTreatment being tested
8 repeated doses of GM1 Ganglioside tbd from the escalation dose (maximum suitable dose). Optional treatment prolongations for 16 weeks (Amendment 2), 8 months (Amendment 3), 4 months (Amendment 4) and 12 months (Amendment 5).
Treatment: Talineuren
- Talineuren dose consolidation with intrapatient dosing (additional patients)Treatment being tested
8 months repeated doses of 720mg GM1 Ganglioside (Amendment 3).
Treatment: Talineuren
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 22 April 2026