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

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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
3
sites
Farmington Hills, Michigan 48334
Phone: 248-957-8940
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Farmington Hills, MI
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Kirkland, Washington 98034
Phone: 425-899-5385
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Kirkland, WA
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Orlando, Florida 32806
Phone: 407-210-1157
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Orlando, FL
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