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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)

Primary Purpose

Parkinson Disease

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo oral capsule
PXT002331 - 20mg
Sponsored by
Prexton Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Levodopa-Induced Dyskinesia (LID), Foliglurax, Parkinson's Disease, mGlu4 PAM

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    PLACEBO

    PXT002331 - 20mg

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 2017
    Last Updated
    March 20, 2018
    Sponsor
    Prexton Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03331848
    Brief Title
    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)
    Acronym
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business reasons
    Study Start Date
    January 15, 2018 (Anticipated)
    Primary Completion Date
    February 1, 2019 (Anticipated)
    Study Completion Date
    February 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Prexton Therapeutics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Levodopa-Induced Dyskinesia (LID), Foliglurax, Parkinson's Disease, mGlu4 PAM

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PLACEBO
    Arm Type
    Placebo Comparator
    Arm Title
    PXT002331 - 20mg
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo oral capsule
    Intervention Description
    BID
    Intervention Type
    Drug
    Intervention Name(s)
    PXT002331 - 20mg
    Intervention Description
    Oral
    Primary Outcome Measure Information:
    Title
    Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia.
    Time Frame
    26 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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).

    12. IPD Sharing Statement

    Learn more about this trial

    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)

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