Health Condition 1: null- Idiopathic Parkinsons Disease Health Condition 2: G20- Parkinsons disease
Conditions
Interventions
Intervention1: Preladenant (SCH 420814): Each morning: 2, 5, or 10 mg preladenant tablet + placebo capsule
Each evening (approximately 8 hours after the morning dose):
2, 5, or 10 mg preladenant table
Sponsors
Merck Sharp and Dohme
Fulford India Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Each subject must have a diagnosis of idiopathic PD for less than 5 years based on the United Kingdom Parkinsonâ??s Disease Society Brain Bank Criteria and the inclusion/exclusion criteria for this protocol. a. Each subject should have bradykinesia and at least one of the following symptoms: • Each subject who is receiving amantadine and/or anticholinergics must have been on a stable regimen of treatment for at least the 5 weeks immediately before Screening. (Note: Subjects who are not taking any medications for PD are permitted to enroll in this trial.) • Each subject must have a UPDRS Part 3 score of ³10. • Each subjectâ??s Hoehn and Yahr Stage must be £3. • Each subject must be willing and able to provide written informed consent for the trial. • Each subject must be ³30 to £85 years of age. A subject may be of either gender and any race/ethnicity. • Each subject must have results of Screening clinical laboratory tests (hematology, blood chemistries, and urinalysis) drawn within 5 weeks prior to Randomization, clinically acceptable to the investigator, and not within the parameters specified for exclusion (below). • All subjects that are sexually active or plan to be sexually active agree to use a highly effective method of birth control while the subject is in the study and for 2 weeks after the last dose of study drug. A male subject must also not donate sperm during the trial and within 2 weeks after the last dose of study drug. Exclusion Criteria: • A subject must not have a form of drug-induced or atypical parkinsonism, cognitive impairment (ie, Montreal Cognitive Assessment [MoCA] score disorder. • A subject must not have a history of any of the following: - repeated strokes with stepwise progression of Parkinsonian features - repeated head injury - definitive encephalitis - oculogyric crises - neuroleptic treatment at onset of symptoms - more than one first degree relative affected - sustained remission - strictly unilateral features after 3 years - supranuclear gaze palsy - cerebellar signs - early severe autonomic involvement - severe symptomatic autonomic involvement unrelated to medications - early severe dementia with disturbances of memory, language, and praxis - Babinski sign with clear, clinically significant pyramidal tract involvement - presence of cerebral tumor or communicating hydrocephalus on neuroimaging (by history) - negative response to large doses of L-dopa (if malabsorption excluded) - MPTP (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine) or known neurotoxin exposure - hallucinations unrelated to medications - stroke within 6 months of Screening or persistent neurological deficit that may interfere with study assessments - surgery for PD • A subject must not have been treated with L-dopa or dopamine agonists for other than diagnostic purposes. If a subject has received L-dopa or dopamine agonists for diagnostic purposes, he/she must not have received the L-dopa or dopamine agonist within 30 days before Randomization. • A subject must not have an untreated major depressive disorder meeting Diagnos
Exclusion criteria
Exclusion criteria: - Must not have a form of drug induced or atypical Parkinsonism, cognitive impairment(ie, Montreal Cognitive Assessment [MoCA] score less than 22), bipolar disorder, untreated major depressive disorder, schizophrenia, or other psychotic disorder; history of exposure to a known neurotoxin, or any neurological features not consistent with the diagnosis of PD as assessed by the investigator. - Must not have had surgery for PD. - Must not have a history of repeated strokes with stepwise progression of Parkinsonism or head injuries, or a stroke within 6 months of Screening; poorly controlled diabetes; abnormal renal function; or a severe or ongoing unstable medical condition. - Must not have an untreated major depressive disorder meeting Diagnostic and Statistical Manual of Mental Disorders IV Text Revision criteria. (A subject who is successfully treated [Beck Depression Inventory, Version II {BDIâ??II} score 19] with stable doses of allowed antidepressant medications for at least the 4 weeks immediately before Screening is eligible to enroll in the trial.). - Must not have failed to show a therapeutic response if a diagnostic levodopa (L dopa) challenge had been done with a large test dose (500 mg) of L dopa (if malabsorption excluded). - Must not have been treated with L dopa or dopamine agonists for other than diagnostic purposes (within 30 days before Screening). - Must not be at imminent risk of self-harm or harm to others. - Must not have elevated blood pressure (BP) (systolic BP greater than or equal to 150 mm Hg or diastolic BP greater than or equal to 95 mm Hg) that cannot be adequately controlled with antihypertensive medication, as demonstrated by 2 BP measurements meeting acceptable BP criterion at consecutive scheduled or unscheduled visits within 5 weeks prior to Randomization. - Must not have had any clinically significant cardiovascular event or procedure for 6 months prior to Randomization, including, but not limited to, myocardial infarction, prolonged QTc interval, angioplasty, unstable angina, or heart failure; and a subject must not have heart failure staged New York Heart Association Class III or IV. - Must not have an alanine aminotransferase (ALT) or aspartate amino transferase (AST) 3 x the upper limit of normal (ULN) or total bilirubin (T BIL) 1.5 x ULN. - Must not have active serologically-confirmed hepatic dysfunction (defined as viral infection [Hepatitis B, C, or E; Epstein-Barr virus (EBV)]; cytomegalovirus [CMV] or a history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank hepatitis, or a history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank hepatitis. - Must not have a history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection. - Must not have received certain prespecified medications or ingested high tyramine-containing aged cheeses (eg, Stilton) for a prespecified time window before the trial, during the trial, and for 2 weeks after the trial. - Must not have an average daily consumption of more than three 4 ounce glasses (118 mL) of wine or the equivalent. <b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in the Sum of Unified Parkinsons Disease Rating Scale Parts 2 and 3 scores (UPDRS2 plus 3)Timepoint: Baseline and Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in the UPDRS Part 2 score (Activities of Daily Living [ADL])Timepoint: Baseline and Week 26;Proportion of Responders (Proportion of participants with a greater than or equal to 20 percent improvement in UPDRS2 plus 3)Timepoint: Baseline and Week 26 | — |
Countries
Argentina, Bulgaria, Canada, Chile, Colombia, Czech Republic, Finland, France, Germany, Hungary, India, Israel, Italy, Mexico, Peru, Poland, Russian Federation, Spain, Sweden, Turkey, United Kingdom, United States of America
Contacts
Public ContactDrMonisha Sharma
MSD Pharmaceuticals Pvt Ltd
Outcome results
None listed