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.

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

sites

Orlando, Florida

Orlando, Florida 32806

Phone: 407-210-1157

from

Orlando, FL