Trials / Terminated
TerminatedNCT03250117
Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
An Open-Label, Relative Bioavailability Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ropinirole Implants in Patients With Parkinson's Disease Switched From Oral Immediate-Release Ropinirole While on L-Dopa
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Titan Pharmaceuticals · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Subjects stable on L-Dopa and oral ropinirole will have their ropinirole replaced with the Ropinirole Implant(s). The Ropinirole Implant was designed using the ProNeura™ implant technology where the implant is inserted under the skin. This study will measure how much ropinirole is released in the blood during 12 weeks of ropinirole implant treatment, and evaluate the side effects of this new formulation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ropinirole oral product | oral immediate-release ropinirole |
| DRUG | Ropinirole Implant | ropinirole hydrochloride/ethylene vinyl acetate |
Timeline
- Start date
- 2017-10-10
- Primary completion
- 2018-05-22
- Completion
- 2018-05-22
- First posted
- 2017-08-15
- Last updated
- 2023-05-06
- Results posted
- 2023-05-06
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03250117. Inclusion in this directory is not an endorsement.