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NCT06431971
Estimates of the Short-term Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease: A Randomized, Placebo-controlled, Double-blinded, Parallel 2-arm, Multi-centre Pilot Trial
Phase 2 trial testing Talineuren in Parkinson Disease in 40 participants. Status unknown.
1 November 2025
Quick facts
| Lead sponsor | InnoMedica Schweiz AG |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 August 2024 |
| Primary completion | 1 November 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Talineuren — full drug profile →
- Placebo
Conditions studied
- Parkinson Disease — all drugs for Parkinson Disease →
Sponsor
InnoMedica Schweiz AG — full company profile →
Who can join
Adults 30 to 85, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Movement Disorder Society Unified Parkinson's Disease Rating Scale score
Time frame: Baseline, week 7, 11, 15, 19 and 22
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used by the patient and physician to evaluate various symptoms of Parkinson disease including non-motor and motor experiences of daily living and motor complications. The MDS-UPDRS Scale consists of 4 parts: * Part 1 (Nonmotor aspects of experiences of daily living) with 13 items. * Part 2 (Motor aspects o
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06431971
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06431971 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by InnoMedica Schweiz AG
- Last refreshed: 21 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06431971.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing