Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients (AMBLED)
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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)
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)
Actual Study Start Date :
July 4, 2017
Estimated Primary Completion Date :
September 15, 2019
Estimated Study Completion Date :
October 1, 2019
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Layout table for eligibility information
Ages Eligible for Study:
35 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.