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

Trial ID: NCT06431971

Interventional - Phase 2 - Unknown status

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.

Conditions

• Parkinson Disease

Interventions

• Talineuren
• Placebo

Eligibility

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

Sponsor

InnoMedica Schweiz AG

Source: ClinicalTrials.gov

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