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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 July 2023
• Main ID: NCT03439943
• Date of registration: 13/02/2018
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Toulouse
• Public title: Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease LixiPark
• Scientific title: Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease
• Date of first enrolment: June 13, 2018
• Target sample size: 156
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03439943
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Olivier. RASCOL, MD, PHD
• Affiliation: University Hospital, Toulouse

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: placebo

Drug: Lixisenatide

Primary Outcome(s)

Change from baseline to end-point (M12) in the MDS-UPDRS III motor (Movement Disorder Society-Unified Parkinson's disease rating scale) [Time Frame: 12 month]

Secondary ID(s)

RC31/16/8912

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Réseau NS-Park

EUCLID Clinical Trial Platform

Sanofi

Cure Parkinson