drugset / Trial / NCT02605434
A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine whether the gastric retentive Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.
Timeline
- Start
- 2016-03
- Primary completion
- 2019-07
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carbidopa | Unknown | 25 mg | Oral |
| Subject | Carbidopa | Unknown | 50 mg | Oral |
| Subject | Levodopa | Small molecule | 100 mg | Oral |
| Subject | Levodopa | Small molecule | 400 mg | Oral |
| Subject | Levodopa | Small molecule | 500 mg | Oral |