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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03250117
• Date of registration: 11/08/2017
• Prospective Registration: Yes
• Primary sponsor: Titan Pharmaceuticals
• Public title: Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
• Scientific title: 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
• Date of first enrolment: October 10, 2017
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03250117
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Dr. Kate Beebe DeVarney
• Affiliation: Titan Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Ropinirole Implant

Drug: Ropinirole oral product

Primary Outcome(s)

AUC of ropinirole [Time Frame: 0-24 hours]

Secondary Outcome(s)

AUC of N-despropyl ropinirole [Time Frame: 0-24 hours]

AUC of 7-hydroxy ropinirole [Time Frame: 0-24 hours]

Secondary ID(s)

ROP-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors