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Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients

A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)

NCT03162874•Prexton Therapeutics

View on ClinicalTrials.gov

Summary

This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)

Eligibility

Age

35 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or females diagnosed after the age of 30 years with idiopathic PD for at least 3 years
•Disease severity of 2 to 4 on the modified Hoehn and Yahr scale when in the OFF state
•Been treated with a stable regimen of levodopa-containing therapy
•Subjects who are on a long-acting formulation of levodopa-containing therapy, including Apodespan PR (or equivalent), must be on a stable dose for at least 6 weeks prior to the first screening visit
•Experienced motor fluctuations with wearing off over a period of at least 3 months prior to randomisation
•Experienced LID over a period of at least 3 months prior to randomisation
•Female subjects will be women of non-childbearing potential
•Subjects must pass a Hauser diary concordance test
•Subjects are able, with or without the help of a caregiver, to understand the purpose and risks of the study and provide signed and dated informed consent and authorisation to use confidential health information in accordance with national and local subject privacy regulations

Exclusion Criteria

•Subjects with atypical, secondary or drug-induced Parkinsonism
•Subjects with a Mini-Mental State Examination (MMSE) score \<25
•Any known contraindication to the use of levodopa, including a history of malignant melanoma or a history of narrow-angle glaucoma.
•Subjects who have had a clinically significant illness within 4 weeks of first dose, as determined by the Investigator.
•Any advanced, severe or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations
•Subjects who have undergone prior neurosurgical operation for PD or transcranial magnetic stimulation.
•Subjects who are participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to the baseline visit.
•Female subjects of childbearing potential
•Subjects who are pregnant (as determined by positive serum pregnancy test at screening and/or baseline), breastfeeding or lactating.
•Subjects who, in the opinion of the Investigator, should not participate in this study.

Locations (45)

Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum

Innsbruck, Austria

Centre Hospitalier Universitaire d'Amiens

Amiens, France

Centre Hospitalier de la Côte Basque

Bayonne, France

Hôpital Avicenne APHP

Bobigny, France

Hôpital Pierre Wertheimer

Bron, France

CHU Gabriel-Montpied

Clermont-Ferrand, France

CHU Grenoble - Pôle Psychiatrie et Neurologie

Grenoble, France

CHRU - Hôpital Roger Salengro

Lille, France

CHU de Nice - Hôpital Pasteur

Nice, France

Hopital Pitie-Salpetriere

Paris, France

Key Dates

Start Date

July 4, 2017

Primary Completion Date

February 19, 2020

Completion Date

March 2, 2020

Last Updated

March 17, 2020

Enrollment

157

ACTUAL participants

Conditions

Parkinson Disease

Interventions

Placebo oral capsule

DRUG

PXT002331 - dose 1

DRUG

PXT002331 - dose 2

DRUG

[18F]F-DOPA Imaging in Patients With Autonomic Failure

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Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients