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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) (ATTUNED)

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ClinicalTrials.gov Identifier: NCT03331848
Recruitment Status : Withdrawn (Business reasons)
First Posted : November 6, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Placebo oral capsule Drug: PXT002331 - 20mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Estimated Study Start Date : January 15, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: PLACEBO Drug: Placebo oral capsule
BID
Experimental: PXT002331 - 20mg Drug: PXT002331 - 20mg
Oral



Primary Outcome Measures :
  1. Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia. [ Time Frame: 26 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Responsible Party: Prexton Therapeutics
ClinicalTrials.gov Identifier: NCT03331848     History of Changes
Other Study ID Numbers: PXT-CL17-003
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prexton Therapeutics:
Levodopa-Induced Dyskinesia (LID)
Foliglurax
Parkinson's Disease
mGlu4 PAM

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs