Status:
TERMINATED
Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
Lead Sponsor:
Titan Pharmaceuticals
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE1
PHASE2
Brief 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 i...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03250117
Start Date
October 10 2017
End Date
May 22 2018
Last Update
May 6 2023
Active Locations (3)
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1
Orlando, Florida
Orlando, Florida, United States, 32806
2
Farmington Hills, Michigan
Farmington Hills, Michigan, United States, 48334
3
Kirkland, Washington
Kirkland, Washington, United States, 98034