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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2018-05-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Subjects receive oral immediate release (IR) ropinirole for 7-10 days, and then are switched to ropinirole implant(s) for 12 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Requip; One Ropinirole Implant

Group Type EXPERIMENTAL

Ropinirole oral product

Intervention Type DRUG

oral immediate-release ropinirole

Ropinirole Implant

Intervention Type DRUG

ropinirole hydrochloride/ethylene vinyl acetate

Cohort 2

Requip; Two Ropinirole Implants

Group Type EXPERIMENTAL

Ropinirole oral product

Intervention Type DRUG

oral immediate-release ropinirole

Ropinirole Implant

Intervention Type DRUG

ropinirole hydrochloride/ethylene vinyl acetate

Cohort 3

Requip; Three Ropinirole Implants

Group Type EXPERIMENTAL

Ropinirole oral product

Intervention Type DRUG

oral immediate-release ropinirole

Ropinirole Implant

Intervention Type DRUG

ropinirole hydrochloride/ethylene vinyl acetate

Cohort 4

Requip; Four Ropinirole Implants

Group Type EXPERIMENTAL

Ropinirole oral product

Intervention Type DRUG

oral immediate-release ropinirole

Ropinirole Implant

Intervention Type DRUG

ropinirole hydrochloride/ethylene vinyl acetate

Interventions

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Ropinirole oral product

oral immediate-release ropinirole

Intervention Type DRUG

Ropinirole Implant

ropinirole hydrochloride/ethylene vinyl acetate

Intervention Type DRUG

Other Intervention Names

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Requip

Eligibility Criteria

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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

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No