At a glance
ClinicalIndex Comparison Record- ✓Participants must have participated in prior study P04501
- ✓Age ≥30 years with diagnosed moderate to severe idiopathic Parkinson's disease
- ✓Prior treatment with L-dopa and/or dopamine agonist
- ✕Discontinued from Study P04501 due to serious adverse event (SAE)
- ✕Drug-induced or atypical parkinsonism
- ✕Cognitive impairment or psychosis
- ✕Current use of tolcapone
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)
In Brief
A Phase 2 clinical trial evaluating Preladenant, L-dopa, and 1 other intervention for Parkinson Disease and 4 related conditions. Completed, enrolled 140 participants.
Detailed 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."
Study Details
Timeline
Interventions
5 mg BID capsules
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).
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.