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

Parkinson Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03250117
• Other study ID #: ROP-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: October 10, 2017
• Est. completion date: May 22, 2018

Study information

• Verified date: April 2023
• Source: Titan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 22, 2018
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Ropinirole oral product
oral immediate-release ropinirole
• Ropinirole Implant
ropinirole hydrochloride/ethylene vinyl acetate

Locations

Country	Name	City	State
United States	Farmington Hills, Michigan	Farmington Hills	Michigan
United States	Kirkland, Washington	Kirkland	Washington
United States	Orlando, Florida	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Titan Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-24 Hours of Ropinirole	Area under the plasma drug concentration-time curve of ropinirole	0-24 hours
Primary	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.	0-12 weeks
Secondary	AUC0-24 Hours of N-despropyl Ropinirole	Area under the plasma drug concentration-time curve of N-despropyl ropinirole	0-24 hours
Secondary	AUC0-24 Hours of 7-hydroxy Ropinirole	Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole	0-24 hours
Secondary	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.	Baseline and Weeks 4, 8 and 12
Secondary	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.	Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12
Secondary	Mean Change From Baseline of Awake Time "Off"	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	Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12