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)

• Status: Withdrawn
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prexton Therapeutics
• Treatments: Levodopa

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).