Trials / Completed
CompletedNCT00537017
Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)
A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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."
Conditions
- Parkinson Disease
- Neurodegenerative Diseases
- Central Nervous System Diseases
- Movement Disorders
- Brain Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Preladenant | 5 mg BID capsules |
| DRUG | L-dopa | 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). |
| DRUG | Other Parkinson's Disease treatments | 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. |
Timeline
- Start date
- 2007-11-23
- Primary completion
- 2009-11-19
- Completion
- 2009-11-19
- First posted
- 2007-09-28
- Last updated
- 2021-02-02
- Results posted
- 2016-12-06
Source: ClinicalTrials.gov record NCT00537017. Inclusion in this directory is not an endorsement.