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

Titan Pharmaceuticals

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: Ropinirole oral product; Drug: Ropinirole Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03250117

ROP-001

Details and patient eligibility

About

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 12 weeks of ropinirole implant treatment, and evaluate the side effects of this new formulation.

Enrollment: 6 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Requip; One Ropinirole Implant

Treatment:

Drug: Ropinirole oral product

Drug: Ropinirole Implant

Cohort 2

Experimental group

Description:

Requip; Two Ropinirole Implants

Treatment:

Drug: Ropinirole oral product

Drug: Ropinirole Implant

Cohort 3

Experimental group

Description:

Requip; Three Ropinirole Implants

Treatment:

Drug: Ropinirole oral product

Drug: Ropinirole Implant

Cohort 4

Experimental group

Description:

Requip; Four Ropinirole Implants

Treatment:

Drug: Ropinirole oral product

Drug: Ropinirole Implant