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)

Overview

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

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 1, 2019

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: PLACEBO
  • Experimental: PXT002331 – 20mg

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Prexton Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor

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