Trials / Completed
CompletedNCT04778176
Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa Via the DopaFuse® Delivery System in Parkinson's Disease Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- SynAgile Corporation · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | continuous oral delivery of levodopa/carbidopa | The system consists of a reusable custom dental retainer, its case, and a pre-filled, single-use container which continuously releases levodopa/carbidopa into the back of the mouth. |
Timeline
- Start date
- 2021-06-16
- Primary completion
- 2022-07-21
- Completion
- 2022-08-02
- First posted
- 2021-03-02
- Last updated
- 2022-08-10
Locations
5 sites across 3 countries: Italy, Luxembourg, Spain
Source: ClinicalTrials.gov record NCT04778176. Inclusion in this directory is not an endorsement.