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)

NCT03331848 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: PXT-CL17-003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Levodopa-Induced Dyskinesia (LID); Foliglurax; Parkinson's Disease; mGlu4 PAM

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia.

  26 days

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

Drug: Placebo oral capsule

PXT002331 - 20mg

EXPERIMENTAL

Drug: PXT002331 - 20mg

Interventions

Placebo oral capsule DRUG

BID

PLACEBO

PXT002331 - 20mg DRUG

Oral

PXT002331 - 20mg

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Prexton Therapeutics: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 6, 2017
• Study Start: January 15, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 22, 2018

Record last verified: 2017-10