Phase 2
Completed N=140
Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)
Parkinson's Disease · Neurodegenerative diseases · Central Nervous System Diseases · Movement Disorders
Source: ClinicalTrials.gov NCT00537017 ↗
Enrolled (actual)
140
Serious AEs
15.7%
Results posted
Dec 2016
Primary outcomePrimary: Number of Participants Who Experienced at Least One Adverse Event — 123 Participants
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."
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced at Least One Adverse Event |
123 | — |
| SECONDARY Time Spent in "Off" State Per Day |
5.6; 4.3; 4.2; 4.0; 3.7; 3.7 | — |
| SECONDARY Awake Time Per Day in the "on" State |
10.6; 11.7; 11.9; 12.0; 12.1; 12.2 | — |
| SECONDARY Time Spent in the "on" State With no Dyskinesias |
6.3; 7.1; 6.8; 6.9; 7.0; 6.9 | — |
| SECONDARY Time Spent in the "on" State With Troublesome Dyskinesias |
1.0; 1.2; 1.4; 1.3; 1.3; 1.4 | — |
| SECONDARY Time Spent in the "on" State Without Troublesome Dyskinesia |
3.3; 3.4; 3.7; 3.8; 3.8; 3.8 | — |
| SECONDARY Absolute Duration of Dyskinesias |
4.3; 4.6; 5.1; 5.1; 5.2; 5.2 | — |
| SECONDARY Total Sleep Time |
7.6; 7.8; 7.7; 7.8; 7.8; 7.7 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have participated in P04501.
- Participants must be >=30 years of age, with a diagnosis of moderate to severe idiopathic Parkinson's disease.
- Participants must have been on a regimen of L-Dopa and/or a dopamine agonist.
Exclusion Criteria
- Participants who discontinued from Study P04501 because they experienced a serious adverse event (SAE)
- Participants with any form of drug-induced or atypical parkinsonism, cognitive impairment, or psychosis
- Participants taking tolcapone
- Participants who are participating in any other clinical study
Data sourced from ClinicalTrials.gov (NCT00537017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.