Parkinson Disease
Conditions
Keywords
Levodopa-Induced Dyskinesia (LID), Foliglurax, Parkinson's Disease, mGlu4 PAM
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
Interventions
DRUGPlacebo oral capsule
BID
DRUGPXT002331 - 20mg
Oral
Sponsors
Prexton Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia. | 26 days |
Outcome results
None listed