Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease (LixiPark)

This is an interventional treatment trial for Parkinson Disease Read More

Inclusion Criteria:

• Patients with PD according to UKPDSBB criteria (male or female).
• Patient with a Hoehn and Yahr Stage <3 in the ON condition.
• Patients aged from 40 to 75 years old.
• Early-stage PD patients: diagnosis of PD for less than 3 years, without dyskinesia and motor fluctuations.
• Patients treated with an "optimized" stable dopaminergic medication regimen (dopamine agonist and/or L-dopa and/or MAOB inhibitor) for at least 1 month before baseline.
• Patients expected to remain on stable doses of antiparkinsonian medications for at least the first 6 months of the study and preferably for the 12 months of follow-up.
• Patients (or caregiver) able to self-administer lixisenatide injection.
• Patients with health insurance.
• Patients who signed the written informed consent form.

Exclusion Criteria:

• Patients suffering from other parkinsonian syndromes other than PD.
• Patients expected not to be able to remain on stable doses of symptomatic antiparkinsonian medications for at least 6-month.
• Patients with a Body Mass Index < 18.5
• Patients suffering from type 1 or type 2 diabetes.
• Malnutrition as assessed clinically by the investigator or any sub-investigator and by Mini Nutritional Assessment Short Form (MNA-SF) score <12 (the judgement of the investigator prevails over questionnaire scores).
• Weight change of more than 5 kg in body weight during the last 3 months prior to screening.
• Known history of drug or alcohol abuse within 6 months prior to the time of screening.
• Patients with hyperthyroidism or uncontrolled hypothyroidism. Note: Patients diagnosed with hypothyroidism need to be on a stable thyroid replacement therapy for at least 6 weeks.
• Patients with severe depression according to DSM criteria.
• Patients with cognitive impairment (MoCA score <26).
• Severe gastrointestinal disease (e.g. gastroparesis).
• Patients previously exposed to a GLP-1 agonist.
• Patients with severely impaired renal function (estimated creatinine clearance <30ml/min).
• Patients with a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or ongoing symptomatic gallbladder disease.
• Patients with any clinically significant ECG abnormality.
• Laboratory findings at the time of screening:

Amylase and/or lipase: >3 times the upper limit of the normal (ULN) laboratory range ALT or AST: >3 times ULN Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome) Calcitonin: >20 pg/mL (5.9 pmol/L) Hemoglobin: <11 g/dL (male/female) and/or neutrophils <1,500/mm3 and/or platelets <100,000/mm3 Triglyceride (TG): >600 mg/dL (6.78 mmol/L). History of unexplained pancreatitis, chronic pancreatitis or pancreatectomy.

• Personal or immediate family history of medullary thyroid cancer or genetic conditions that predispose to medullary thyroid cancer (e.g. multiple endocrine neoplasia syndromes).
• Hyperlipidemia.
• Females who are pregnant, breast feeding or of child bearing age without effective contraception.
• Patients treated per os in the evening by drugs requiring a rapid action (at the discretion of the investigator).
• Participants who lack the capacity to give informed consent.
• Any medical or psychiatric condition which may compromise participation in the study or the safety, at the discretion of the investigator.
• Known abnormality on CT or MRI brain imaging that is considered likely to compromise compliance with any aspect of the trial.
• Prior intra-cerebral surgical intervention for PD.
• Participant under legal guardianship or incapacitation.
• Patients who are participating or have participated in another interventional clinical trial within 30 days prior to baseline.
• Previous enrolment in the present trial.
• Allergic reaction to the active substance or to any of the excipients of lixisenatide