Parkinson Disease Clinical Trial
— LixiParkOfficial title:
Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease
Verified date | June 2023 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 156 |
Est. completion date | April 15, 2021 |
Est. primary completion date | April 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Amiens | Amiens | |
France | University Hospital of Besancon | Besancon | |
France | University Hospital of Bordeaux | Bordeaux | |
France | University Hospital of Caen | Caen | |
France | University Hospital of Clermont-Ferrand | Clermont-Ferrand | |
France | Creteil- Henri Mondor Hospital | Créteil | |
France | University Hospital of Lille | Lille | |
France | University Hospital of Limoges | Limoges | |
France | University Hospital of Lyon | Lyon | |
France | University Hospital of Marseille | Marseille | |
France | University Hospital of Montpellier | Montpellier | |
France | University Hospital of Nancy | Nancy | |
France | University Hospital of Nantes | Nantes | |
France | University Hospital of Nice | Nice | |
France | Pitié Salpêtrière Hospital | Paris | |
France | University Hospital of Poitiers | Poitiers | |
France | University Hospital of Rennes | Rennes | |
France | University Hospital of Rouen | Rouen | |
France | University Hospital of Strasbourg | Strasbourg | |
France | CHU Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse | Cure Parkinson, EUCLID Clinical Trial Platform, Réseau NS-Park, Sanofi |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline to end-point (M12) in the MDS-UPDRS III motor (Movement Disorder Society-Unified Parkinson's disease rating scale) | 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. The primary endpoint of this study is the change from baseline to end-point (M12) in the MDS-UPDRS III motor examination score, evaluated in the best ON condition in patients with early Parkinson's Disease. |
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