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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the study is to evaluate the effect of lixisenatide (20 μg/d), versus placebo, administered as add-on therapy with the usual antiparkinsonian treatment, on the progression of motor disability in patients with early PD in order to assess its potential "disease-modifying" effect.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Collaborators: Cure Parkinson; EUCLID; EUCLID Clinical Trial Platform; Réseau NS-Park; Sanofi
• Treatments: Lixisenatide

Criteria

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