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

Phase 1

Terminated

• Conditions: Parkinson Disease
• Interventions: Drug: Ropinirole oral product; Drug: Ropinirole Implant

• Registration Number: NCT03250117
• Lead Sponsor: Titan Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-15
• Study Start: 2017-10-10
• Primary Completion: 2018-05-22
• Study Completion: 2018-05-22
• Disposition First Submitted: 2020-01-23
• Results First Submitted: 2023-02-28
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-10
• Last Update Submitted: 2023-04-10
• Results First Posted: 2023-05-06
• Disposition First Posted: 2023-05-06
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 2	Ropinirole oral product	Requip; Two Ropinirole Implants
Cohort 3	Ropinirole Implant	Requip; Three Ropinirole Implants
Cohort 4	Ropinirole oral product	Requip; Four Ropinirole Implants
Cohort 4	Ropinirole Implant	Requip; Four Ropinirole Implants
Cohort 2	Ropinirole Implant	Requip; Two Ropinirole Implants
Cohort 3	Ropinirole oral product	Requip; Three Ropinirole Implants
Cohort 1	Ropinirole oral product	Requip; One Ropinirole Implant
Cohort 1	Ropinirole Implant	Requip; One Ropinirole Implant

Primary Outcome Measures

Name	Time	Method
AUC0-24 Hours of Ropinirole	0-24 hours	Area under the plasma drug concentration-time curve of ropinirole
Total Number of Adverse Events Across Participants	0-12 weeks	Safety and tolerability of ropinirole implant(s) presented as the total number of adverse events experienced by the analysis population.

Secondary Outcome Measures

Name	Time	Method
AUC0-24 Hours of N-despropyl Ropinirole	0-24 hours	Area under the plasma drug concentration-time curve of N-despropyl ropinirole
Mean Change From Baseline of Awake Time "On"	Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12	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.
AUC0-24 Hours of 7-hydroxy Ropinirole	0-24 hours	Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole
Mean Change From Baseline in MDS-UPDRS Total Score	Baseline and Weeks 4, 8 and 12	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.
Mean Change From Baseline of Awake Time "Off"	Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12	Efficacy of ropinirole implants presented as mean change from baseline of awake time "Off". 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). "Off" refers to when medication has worn off and is no longer providing benefit with regard to mobility, slowness and stiffness. Daily totals for waking hours were normalized to a 16-hour waking day and averaged across the 2 days

Trial Locations

Locations (3)

Orlando, Florida; 🇺🇸 Orlando, Florida, United States

Kirkland, Washington; 🇺🇸 Kirkland, Washington, United States

Farmington Hills, Michigan; 🇺🇸 Farmington Hills, Michigan, United States