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Withdrawn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
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
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
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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