None listed
Conditions
Interventions
Group 1 Type of group
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
Group name:Group 5 Type of group
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Age
30 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Must have a diagnosis of moderate to severe idiopathic Parkinson´s disease. • Must have received prior therapy with L dopa for approximately 1 or more years immediately before Screening and must continue to have a beneficial clinical response to L dopa • Must have been on a stable dopaminergic treatment regimen for at least the 5 weeks immediately before Randomization. Participants receiving other adjunctive treatments (eg, dopamine agonists, anticholinergics, entacapone) or taking only L dopa are permitted, provided the treatment regimen has been taken for at least 5 weeks prior to randomization • Must be experiencing motor fluctuations with or without dyskinesias within the 4 weeks immediately before Screening, must be experiencing a minimum of 2 hours/day of off time, and have a Hoehn & Yahr stage between 2.5 and 4 when in the on state • Must be capable of maintaining an accurate and complete symptom diary and to adhere to dose and visit schedules with or without the help of a caregiver • Must have results of a physical examination and screening clinical laboratory tests clinically acceptable to the investigator • If sexually active or plan to be sexually active agree to use a highly effective method of birth control while in the study and for 2 weeks after the last dose of study drug. Males must also not donate sperm during the trial within 2 weeks after the last dose of study drug
Exclusion criteria
Exclusion criteria: • Must not have a form of drug induced or atypical parkinsonism, a cognitive impairment, 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 a history of repeated strokes or head injuries, or a stroke within 6 months of Screening • Must not have poorly-controlled diabetes or abnormal renal function • Must not have had surgery for their PD • Must not be at imminent risk of self-harm or harm to others • Must not have sleep attacks or compulsive behavior that would interfere with the integrity of the trial or would pose a risk to the subject in participating in the trial • Must not have a systolic blood pressure (BP) =150 mm Hg OR diastolic BP =95 mm Hg at Screening • Must not have had any clinically significant cardiovascular event or procedure for 6 months prior to study start, including, but not limited to, myocardial infarction, angioplasty, unstable angina, or heart failure; and 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 a history of serologically confirmed hepatic dysfunction (defined as viral infection [Hepatitis B or C; Epstein Barr virus (EBV); cytomegalovirus (CMV)]) 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 • Must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence) • Must not have allergy/sensitivity to investigational product(s) or its/their excipients • A female subject must not be breast-feeding, considering breast-feeding, pregnant, or intending to become pregnant • Must not have used preladenant ever, or any investigational drugs within 90 days immediately before Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The on state is defined as the period of time during which a patients symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect. Measure:Change From Baseline in Mean Off Time Timepoints:Baseline and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The number of participants with Systolic Blood Pressure >=180 mm Hg was reported. Measure:Number of Participants With Systolic Blood Pressure >=180 mm Hg Timepoints:Up to Week 14 ; Outcome name:The number of participants with Diastolic Blood Pressure >=105 mm Hg was reported. Measure:Number of Participants With Diastolic Blood Pressure >=105 mm Hg Timepoints:Up to Week 14 ; Outcome name:The number of participants with alanine aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported. Measure:Number of Participants With Alanine Aminotransferase >=3 Times the Upper Limit of Normal Timepoints:Up to Week 14 ; Outcome name:The number of participants with aspartate aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported. Measure:Number of Participants With Aspartate Aminotransferase >=3 Times the Upper Limit of Normal Timepoints:Up to Week 14 ; Outcome name:The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan. Measure:Percentage of Participants With Suicidality Timepoints:Up to Week 12 ; Outcome name:The ESS is a self-administered questionnaire providing a measure of a persons general level of daytime sleepiness, or their average sleep propensity in daily life. The | — |
Countries
Austria, Brazil, Bulgaria, Canada, Finland, France, Germany, India, Israel, Italy, Japan, Netherlands, Peru, Poland, Portugal, Russian Federation, Spain, Sweden, Turkey, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed