Estimates of the Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease

Prior treatment

• Previous treatment with Talineuren (i.e. participants from NEON trial are not allowed)
• Prior Campylobacter-jejuni-gastroenteritis or prior occurrence of Guillain-Barré-Syndrome.
• Participation in another trial with an investigational drug within the 30 days preceding and during the present trial.
• Patients with clinically significant concomitant diseases (e.g., renal failure, hepatic dysfunction, cardiovascular disease, infections, etc.) that are not under stable control.
• Known or suspected non-compliance, drug or alcohol abuse.
• Concomitant use of myelotoxic (e.g. cytostatic agents) and/or other drugs with clinically relevant immunosuppressive effects (e.g. calcineurin inhibitors) and/or drugs associated with a clinically relevant impairment of granulopoiesis.

Other illness

• Contraindications to the drug classes of standard of care medication and the investigational medicinal product, (e.g., known hypersensitivity or allergy) and contraindications as listed in the product information of marketed products.
• Inability to follow the procedures of the trial, e.g., due to language problems, psychological disorders etc. of the participant.
• Subject has an atypical parkinsonian syndrome or secondary parkinsonism.
• Patients with an established diagnosis of clinically relevant bone marrow dysfunction affecting leukopoiesis or with active hematological malignancies or with a clinically relevant immunodeficiency.

Other

• Known / suspected diagnosis of hereditary fructose intolerance.
• 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.
• 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.
• Enrolment of the investigator, his/her family members, employees and other dependent persons.
• Patients in adjustment of deep brain stimulation (DBS) parameters
• Patients with comorbidity that may interfere with the course of the trial.
• Patients who are not considered to be eligible to participate in clinical trial by the investigator.

• Informed consent as documented by signature.
• Male and female subjects, aged 30 to 85 years.
• Confirmed PD according to British brain bank criteria.
• Hoehn and Yahr Stage 0 - 2.5 on medication and on stimulation (DBS, if applicable).
• Stable dopaminergic PD treatment (including DBS) for a month at least.
• Absence of dementia confirmed by cognitive testing (MoCA ≥24).