Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole

• Status: Terminated
• Trial end date: 2018-05-22
• Target enrollment: 0
• Participant gender: All

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 3 months of treatment, and evaluate the side effects of this new formulation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Titan Pharmaceuticals
• Treatments: Dopamine; Ropinirole

Criteria

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