Study to Evaluate the Efficacy, Safety, and Tolerability of PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED) (ATTUNED)
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This is a Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing Motor Complications of Levodopa Therapy
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety, and Tolerability of 8-week Oral Treatment With PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)
Estimated Study Start Date :
January 15, 2018
Estimated Primary Completion Date :
February 1, 2019
Estimated Study Completion Date :
February 1, 2019
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Ages Eligible for Study:
35 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Between 35 and 85 years of age, inclusive, at the time of signing informed consent
Diagnosed after the age of 30 years with idiopathic PD
A documented medical history of 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 must be receiving at least 3 doses per day of levodopa-containing therapy, and must be on a stable dose for at least 2 weeks for immediate-release levodopa or at least 6 weeks for prolonged-release levodopa preparations prior to the first screening visit
Experienced LID over a period of at least 3 months prior to randomization
If needed, in the opinion of the investigator, subjects must have a caregiver
Female subjects will be women of non-childbearing potential
Patient is currently participating in or has participated in another study in the last 3 months
Subjects with atypical, secondary, or drug-induced Parkinsonism
Subjects with a history of dyskinesia that was exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic without peak-dose dyskinesia
Subjects with a MoCA score of <25
Subjects who have, or who had a history of, any clinically significant hepatic or gallbladder disorder, as determined by the investigator
Subjects who have dementia, currently active psychosis, or hallucinations.
Suicide attempt within 1 year prior to the first screening visit, or severe suicidal ideation within 6 months prior to the first screening visit
Subject has a current diagnosis of epilepsy,
Any known contraindication to the use of levodopa, including a history of malignant melanoma or a history of narrow-angle glaucoma
Carcinoma or successfully treated squamous cell carcinoma of the skin and no sing of disease recurrence for at least 5 years
Subjects who have had a clinically significant illness within 4 weeks before the first dose, as determined by the investigator
Subjects with scheduled surgeries/hospitalizations during the study period
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,
Subjects currently taking (or expected to be administered during the course of the study) any of the prohibited medications (amantadine, safinamide, dopamine-antagonists).