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

Phase 2TerminatedNCT03250117

Titan Pharmaceuticals6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

Ropinirole oral productDRUG

oral immediate-release ropinirole

Ropinirole ImplantDRUG

ropinirole hydrochloride/ethylene vinyl acetate

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Orlando, Florida

Orlando, Florida, United States

Farmington Hills, Michigan

Farmington Hills, Michigan, United States

Kirkland, Washington

Kirkland, Washington, United States

Outcomes

Primary Outcomes

AUC0-24 Hours of Ropinirole

Area under the plasma drug concentration-time curve of ropinirole

Time frame: 0-24 hours

Total Number of Adverse Events Across Participants

Safety and tolerability of ropinirole implant(s) presented as the total number of adverse events experienced by the analysis population.

Time frame: 0-12 weeks

Secondary Outcomes

AUC0-24 Hours of N-despropyl Ropinirole

Area under the plasma drug concentration-time curve of N-despropyl ropinirole

Time frame: 0-24 hours

AUC0-24 Hours of 7-hydroxy Ropinirole

Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole

Time frame: 0-24 hours

Mean Change From Baseline in MDS-UPDRS Total Score

Efficacy of ropinirole implants presented as the mean change from baseline in MDS-UPDRS total score. Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Scale \[MDS-UPDRS\] is a questionnaire and examination rating motor and non-motor experiences, and motor complications. Score is summed to range from 0 to 272. Higher score indicates more severe symptoms/outcome.

Time frame: Baseline and Weeks 4, 8 and 12

Mean Change From Baseline of Awake Time "On"

Efficacy of ropinirole implants presented as mean change from baseline of awake time "on". Diaries were completed for 2 consecutive days prior to the visit, used to record motor state in half-hour intervals over a 24-hour period (during waking hours). "On" refers to when medication is providing benefit with regard to mobility, slowness and stiffness, regardless of dyskinesia. Daily totals for waking hours were normalized to a 16-hour waking day and averaged across the 2 days.

Data from ClinicalTrials.gov

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