Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease
LixiPark
Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease
1 other identifier
interventional
156
1 country
20
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 motor disability in patients with early PD in order to assess its potential "disease-modifying" effect.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 parkinson-disease
Started Jun 2018
Typical duration for phase_2 parkinson-disease
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2018
CompletedFirst Posted
Study publicly available on registry
February 20, 2018
CompletedStudy Start
First participant enrolled
June 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2021
CompletedNovember 28, 2025
June 1, 2023
2.8 years
February 13, 2018
November 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 month
Study Arms (2)
Lixisenatide
EXPERIMENTALLixisenatide (10μg/d for 14 days and then 20μg/d): once daily subcutaneous
Placebo
PLACEBO COMPARATORPlacebo: once daily subcutaneous injection
Interventions
Patients randomized in the Lixisenatide group will receive 10μg/day for 14 days and then 20μg/day administered by once-daily subcutaneous injections during 12 months. If patients are unable to tolerable the dose of 20μg/day, this dose can be reduced to 10μg/day
Patients randomized in the placebo group will receive the corresponding placebo administered subcutaneously (once daily subcutaneous injection).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- Cure Parkinson'scollaborator
- Réseau NS-Parkcollaborator
- EUCLID Clinical Trial Platformcollaborator
- Sanoficollaborator
Study Sites (20)
University Hospital of Amiens
Amiens, France
University Hospital of Besancon
Besançon, 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, 31000, France
Related Publications (1)
Meissner WG, Remy P, Giordana C, Maltete D, Derkinderen P, Houeto JL, Anheim M, Benatru I, Boraud T, Brefel-Courbon C, Carriere N, Catala H, Colin O, Corvol JC, Damier P, Dellapina E, Devos D, Drapier S, Fabbri M, Ferrier V, Foubert-Samier A, Frismand-Kryloff S, Georget A, Germain C, Grimaldi S, Hardy C, Hopes L, Krystkowiak P, Laurens B, Lefaucheur R, Mariani LL, Marques A, Marse C, Ory-Magne F, Rigalleau V, Salhi H, Saubion A, Stott SRW, Thalamas C, Thiriez C, Tir M, Wyse RK, Benard A, Rascol O; LIXIPARK Study Group. Trial of Lixisenatide in Early Parkinson's Disease. N Engl J Med. 2024 Apr 4;390(13):1176-1185. doi: 10.1056/NEJMoa2312323.
PMID: 38598572RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier. RASCOL, MD, PHD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2018
First Posted
February 20, 2018
Study Start
June 13, 2018
Primary Completion
April 15, 2021
Study Completion
April 15, 2021
Last Updated
November 28, 2025
Record last verified: 2023-06