Status:
COMPLETED
Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Cure Parkinson's
Réseau NS-Park
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief 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 mot...
Detailed Description
This study will be a French, multicenter parallel groups, 2-arm, randomized, placebo-controlled, double-blind, proof-of-concept (POC) phase II trial evaluating the effect of lixisenatide, in patients ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03439943
Start Date
June 13 2018
End Date
April 15 2021
Last Update
November 28 2025
Active Locations (20)
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1
University Hospital of Amiens
Amiens, France
2
University Hospital of Besancon
Besançon, France
3
University Hospital of Bordeaux
Bordeaux, France
4
University Hospital of Caen
Caen, France