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)

Parkinson Disease Clinical Trial

— ATTUNED  

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03331848
• Other study ID #: PXT-CL17-003
• Status: Withdrawn
• Phase: Phase 2
• First received: November 1, 2017
• Last updated: March 20, 2018
• Start date: January 15, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: October 2017
• Source: Prexton Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease

Intervention

Drug:
• Placebo oral capsule
BID
• PXT002331 - 20mg
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prexton Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia.		26 days