drugset / Trial / NCT01215227
An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary purpose of this extension study is to assess the long-term safety and tolerability of preladenant in participants from parent studies NCT01155466 \[P04938\] and NCT01227265 \[P07037\] with moderate to severe Parkinson's Disease (PD). The study will also characterize the long-term efficacy of preladenant in participants with PD. Participants will continue to receive their stable regimen of levodopa (L-dopa) plus any adjunct medications during the study as prescribed by their physician. Several classes of adjunct medications may be used, including Amantadine, anticholinergics, dopa decarboxylase inhibitors, and dopamine agonists.
Timeline
- Start
- 2010-11-18
- Primary completion
- 2013-07-16
- Completion
- 2013-07-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Preladenant | Small molecule | 2 mg | Oral |
| Subject | Preladenant | Small molecule | 5 mg | Oral |
| Subject | Preladenant | Small molecule | 10 mg | Oral |
| Subject | Rasagiline | Small molecule | 1 mg | Oral |