Completed
PHASE2
INTERVENTIONAL
NCT00537017
Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in the main study (P04501; NCT00406029) entitled "A Phase 2, 12 Week, Double Blind, Dose Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias."
Interventions
Name:
Preladenant
Type:
DRUG
Description:
5 mg BID capsules
Name:
L-dopa
Type:
DRUG
Description:
Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).
Name:
Other Parkinson's Disease treatments
Type:
DRUG
Description:
Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O methyl transferase (COMT) inhibitor entacapone.
Primary Outcomes
Measure:
Number of Participants Who Experienced at Least One Adverse Event
TimeFrame:
Up to 42 weeks
Description:
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. A serious adverse event is an adverse event that that results in death, life threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.
Trial Information
NCT ID
NCT00537017
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Merck Sharp & Dohme LLC
Last Updated
December 15, 2025