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NOT YET RECRUITING

NCT06431971

PHASE2

Estimates of the Short-term 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 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.

Official title: 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

Key Details

Gender

All

Age Range

30 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08

Completion Date

2025-12

Last Updated

2024-05-29

Healthy Volunteers

Conditions

Parkinson Disease

Interventions

DRUG

Talineuren

Talineuren infusion weekly

DRUG

Placebo

Placebo infusion weekly

Inclusion Criteria: 1. Informed consent as documented by signature. 2. Male and female subjects, aged 30 to 85 years. 3. Confirmed PD according to British brain bank criteria. 4. Hoehn and Yahr Stage 0 - 2.5 on medication. 5. Stable dopaminergic PD treatment (including DBS) for a month at least. 6. Absence of dementia confirmed by cognitive testing (MoCA ≥24). Exclusion Criteria: 1. Previous treatment with Talineuren (i.e. participants from NEON trial are not allowed) 2. Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to class of drugs or the investigational products. 3. Women who are pregnant or breast feeding, or planning to become pregnant during the course of the trial or in the 12 weeks following the trial. 4. Lack of safe contraception, defined as: * Female participants of childbearing potential, not willing to use double method of contraception (hormonal and mechanical) for the entire study duration. Note: Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential. * Male participants, not using and not willing to use a medically reliable method of contraception for the entire study duration, such as condoms or who are not using any other method considered sufficiently reliable by the investigator in individual cases. 5. Other clinically significant concomitant diseases states (e.g., renal failure, hepatic dysfunction, cardiovascular disease etc.) that is are not under stable control. 6. Known or suspected non-compliance, drug or alcohol abuse. 7. Inability to follow the procedures of the trial, e.g., due to language problems, psychological disorders etc. of the participant. 8. Participation in another trial with an investigational drug within the 30 days preceding and during the present trial. 9. Enrolment of the investigator, his/her family members, employees and other dependent persons. 10. Subject has an atypical parkinsonian syndrome or secondary parkinsonism. 11. Patients with comorbidity that may interfere with the course of the trial. 12. Patients who are not considered to be eligible to participate in clinical trial by the investigator. 13. Patients in adjustment of deep brain stimulation (DBS) parameters 14. Patients with known impaired granulopoiesis

Locations (1)

Neurologisches Institut Konolfingen

Konolfingen, Switzerland