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)

Phase 2

Withdrawn

• Conditions: Parkinson Disease
• Interventions: Drug: Placebo oral capsule; Drug: PXT002331 - 20mg

• Registration Number: NCT03331848
• Lead Sponsor: Prexton Therapeutics

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Study Start: 2018-01-15
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO	Placebo oral capsule	-
PXT002331 - 20mg	PXT002331 - 20mg	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia.	26 days