drugset / Trial / NCT04778176
Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa Via the DopaFuse® Delivery System in Parkinson's Disease Patients
Phase 2
Completed
17 enrolled
SynAgile Corporation
Clinical Data Science GmbH · collabClintrex Research Corporation · collabTFS Trial Form Support · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate whether the DopaFuse System can reduce the fluctuation of plasma levodopa levels compared to participants' standard intermittent doses of oral LD/CD tablets (background treatment). It will also assess whether the system is safe, well tolerated, and can relieve motor symptoms.
Timeline
- Start
- 2021-06-16
- Primary completion
- 2022-07-21
- Completion
- 2022-08-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carbidopa | Unknown | 13 mg | Oral |
| Subject | Carbidopa | Unknown | 17 mg | Oral |
| Subject | Levodopa | Small molecule | 50 mg | Oral |
| Subject | Levodopa | Small molecule | 68 mg | Oral |