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)

NCT ID: NCT03331848

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2019-02-01

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

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PLACEBO

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

BID

PXT002331 - 20mg

Group Type: EXPERIMENTAL

PXT002331 - 20mg

Intervention Type: DRUG

Oral

Interventions

Placebo oral capsule

BID

Intervention Type: DRUG

PXT002331 - 20mg

Oral

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prexton Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PXT-CL17-003

Identifier Type: -

Identifier Source: org_study_id