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

NCT03439943 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-11-28

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

DRUG

placebo

Patients randomized in the placebo group will receive the corresponding placebo administered subcutaneously (once daily subcutaneous injection).

DRUG

Lixisenatide

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

Sponsors & Collaborators

  • Cure Parkinson's

    collaborator OTHER

  • Réseau NS-Park

    collaborator UNKNOWN

  • EUCLID Clinical Trial Platform

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Olivier. RASCOL, MD, PHD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-13
Primary Completion
2021-04-15
Completion
2021-04-15

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03439943 on ClinicalTrials.gov