Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
| Status: | Recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - 80 |
| Updated: | 12/3/2017 |
| Start Date: | October 10, 2017 |
| End Date: | December 2018 |
| Contact: | Titan Pharmaceuticals |
| Email: | ROP-001@titanpharm.com |
| Phone: | 650-244-4990 |
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
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 3 months of treatment, and evaluate the side
effects of this new formulation.
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 3 months of treatment, and evaluate the side
effects of this new formulation.
Key Inclusion Criteria:
- Voluntarily provided informed consent
- Meet diagnostic criteria for idiopathic Parkinson's Disease
- On L-Dopa and oral ropinirole
- If female of child-bearing potential, willing to practice contraception from time of
informed consent to Follow-Up Visit
Key Exclusion Criteria:
- Pregnant, breastfeeding, or planning to become pregnant
- Active epilepsy within the past year
- Severe dementia or cognitive impairment
- Donated or lost > 400 mL of blood within 1 month prior to Screening
- History of alcohol or substance use disorder within the prior 12 months
- Recent episodes of moderate to severe dizziness or syncope
- Definite or suspected hypersensitivity to ropinirole or ethylene vinyl acetate
- Used any other investigational drug within 60 days or 5 half-lives prior to Screening,
or plan to take any such drug any time during the study
We found this trial at
3
sites
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