Back to resultsRelative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
Primary Purpose
Parkinson Disease
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ropinirole oral product
Ropinirole Implant
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Dyskinesia, ropinirole, implant, ProNeura, movement disorders, dopamine agonist, extended-release, Parkinsonian disorders, brain diseases, central nervous system diseases, Neurodegenerative Diseases, Antiparkinson agents, Anti-dyskinesia agents, dopamine agents, neurotransmitter agents, REQUIP, subdermal
Eligibility 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
Sites / Locations
- Orlando, Florida
- Farmington Hills, Michigan
- Kirkland, Washington
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
Requip; One Ropinirole Implant
Requip; Two Ropinirole Implants
Requip; Three Ropinirole Implants
Requip; Four Ropinirole Implants
Outcomes
Primary Outcome Measures
AUC0-24 Hours of Ropinirole
Area under the plasma drug concentration-time curve of ropinirole
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.
Secondary Outcome Measures
AUC0-24 Hours of N-despropyl Ropinirole
Area under the plasma drug concentration-time curve of N-despropyl ropinirole
AUC0-24 Hours of 7-hydroxy Ropinirole
Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03250117
Brief Title
Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated for reasons not related to efficacy or safety
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
May 22, 2018 (Actual)
Study Completion Date
May 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Titan Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Dyskinesia, ropinirole, implant, ProNeura, movement disorders, dopamine agonist, extended-release, Parkinsonian disorders, brain diseases, central nervous system diseases, Neurodegenerative Diseases, Antiparkinson agents, Anti-dyskinesia agents, dopamine agents, neurotransmitter agents, REQUIP, subdermal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Subjects receive oral immediate release (IR) ropinirole for 7-10 days, and then are switched to ropinirole implant(s) for 12 weeks.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Requip; One Ropinirole Implant
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Requip; Two Ropinirole Implants
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Requip; Three Ropinirole Implants
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Requip; Four Ropinirole Implants
Intervention Type
Drug
Intervention Name(s)
Ropinirole oral product
Other Intervention Name(s)
Requip
Intervention Description
oral immediate-release ropinirole
Intervention Type
Drug
Intervention Name(s)
Ropinirole Implant
Intervention Description
ropinirole hydrochloride/ethylene vinyl acetate
Primary Outcome Measure Information:
Title
AUC0-24 Hours of Ropinirole
Description
Area under the plasma drug concentration-time curve of ropinirole
Time Frame
0-24 hours
Title
Total Number of Adverse Events Across Participants
Description
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 Outcome Measure Information:
Title
AUC0-24 Hours of N-despropyl Ropinirole
Description
Area under the plasma drug concentration-time curve of N-despropyl ropinirole
Time Frame
0-24 hours
Title
AUC0-24 Hours of 7-hydroxy Ropinirole
Description
Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole
Time Frame
0-24 hours
Title
Mean Change From Baseline in MDS-UPDRS Total Score
Description
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
Title
Mean Change From Baseline of Awake Time "On"
Description
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.
Time Frame
Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12
Title
Mean Change From Baseline of Awake Time "Off"
Description
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
Time Frame
Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Kate Beebe DeVarney
Organizational Affiliation
Titan Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Orlando, Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Farmington Hills, Michigan
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Kirkland, Washington
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
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