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Trial · Interventional

CompletedPhase 2Registry data

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

Short name LixiPark

Overview

Status
Completed
Phase
Phase 2
Enrollment
156 participants (actual)
Sponsor
University Hospital, Toulouse · Other
Design
Randomized · Quadruple masking
Countries
1 country

France

Start
13 Jun 2018
Primary completion
15 Apr 2021
Completion
15 Apr 2021
First posted
20 Feb 2018
Last update posted
28 Nov 2025
Conditions
Parkinson Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019202020212022
  1. Ph 2

    LixiPark

    NCT03439943

    13 Jun 2018 to 15 Apr 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LixisenatideDrug
  • placeboDrug

Arms2

  • Experimental

    Lixisenatide

    Lixisenatide (10μg/d for 14 days and then 20μg/d): once daily subcutaneous

  • Placebo comparator

    Placebo

    Placebo: once daily subcutaneous injection

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

5 results

Trial of Lixisenatide in Early Parkinson's Disease.

Meissner et al. 2024The New England journal of medicinecited by 298

PMID 38598572DOI 10.1056/nejmoa2312323PUB-38598572

Full text at the publisher5 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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