Parkinson's disease MedDRA version: 14.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Preladenant
Product Code: SCH 420814
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Preladenant
CAS Number: 377727-87-2
Current Sponsor code: SCH 420814
Concentration unit: mg m
Sponsors
Schering-Plough Research Institute, a division of Schering Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Each subject must have a diagnosis of idiopathic PD based on the UK Parkinson’s Disease Society Brain Bank Criteria (Appendix 1) and the inclusion/exclusion criteria for this protocol. Each subject should have bradykinesia and at least one of the following symptoms: i. Muscular rigidity ii. Resting tremor (4 to 6 Hz); Please note that for the purposes of this study, a diagnosis based solely on bradykinesia and postural instability is insufficient for diagnosis of idiopathic Parkinson's Disease, and subjects diagnosed in this manner cannot be enrolled in the study). • Each subject 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 at Screening. • Each subject must have been on a stable, optimal dopaminergic treatment regime regimen, defined as maximum therapeutic effect achieved with available anti parkinsonian treatment, for at least the 5 weeks immediately before Randomization. Subjects receiving the adjunct PD medications listed in Table 1 are permitted to enroll in this trial. Each subject who is receiving one or more of the adjunct PD medications listed in Table 1 must have been on a stable regimen of treatment for at least the 5 weeks immediately before Randomization. • Each subject’s Hoehn and Yahr stage must be >= 2.5 and =30 to <=85 years of age. A subject may be of either sex, 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). • Each subject must have results of a physical examination within normal limits or clinically acceptable limits to the investigator. • Each subject must be able to adhere to dose and visit schedules. • 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 within 2 weeks after the last dose of study drug. Complete details regarding contraceptive requirements are specified in protocol Section 7.7.2.7. Are the trial subjects under 18? no Number of subjects for this age ran
Exclusion criteria
Exclusion criteria: • A subject must not have a form of drug induced or atypical parkinsonism, cognitive impairment (ie, Montreal Cognitive Assessment [MoCA] score = 150mm Hg OR diastolic BP >= 95mm Hg at Screening or at a BP recheck prior to Randomization. Should the BP remain elevated, the subject may not enter the trial until the BP has been adequately controlled with antihypertensive medication as demonstrated by 2 BP measurements meeting this criterion at consecutive separate visits (scheduled or unscheduled) within 5 weeks prior to Randomization. If antihypertensive medications are used to control a subject’s BP, the subject’s BP and doses of antihypertensive medications must be stable for at least 2 weeks prior to randomization. Note: During the course of the study, antihypertensive medication maybe initiated or increased to control a subject's BP at anytime during treatment in P04938 as needed. • A subject 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 [a subject must not have a QTc result > 500 msec], angioplasty, unstable angina, or heart failur
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The proportion of Responders, where a Responder is defined as a subject with at least a 30% reduction in mean "off" time from Baseline to Week 12. - The change from Baseline to Week 12 in mean "on" time without troublesome dyskinesia in hours per day. ;Timepoint(s) of evaluation of this end point: 2,4,8, and 12 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Primary Efficacy Objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with moderate to severe Parkinson's disease (PD) experienceing motor fluctuations and receiving a stable dose of levodopa (L-dopa), as measured by "off" time.;Secondary Objective: The Key Secondary Efficacy Objective for this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with moderate to severe PD experiencing motor fluctuations and receiving a stable dose of L-dopa, as measured by the proportion of Responders and by “on” time without troublesome dyskinesia.;Primary end point(s): The Change from Baseline to End of Treatment (Week 12) in mean "off" time in hours per day.;Timepoint(s) of evaluation of this end point: 2,4,8, and 12 weeks | — |
Countries
Austria, Brazil, Bulgaria, Canada, Czech Republic, Finland, France, Germany, India, Israel, Italy, Netherlands, Peru, Poland, Portugal, Russian Federation, Spain, Sweden, Turkey, United Kingdom, United States
Contacts
Public ContactKenneth Wolski, MD
Schering-Plough Research Institute, a division of Schering Corporation
Outcome results
None listed