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This study was terminated for reasons not related to efficacy or safety
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Requip; One Ropinirole Implant |
|
| Cohort 2 | Experimental | Requip; Two Ropinirole Implants |
|
| Cohort 3 | Experimental | Requip; Three Ropinirole Implants |
|
| Cohort 4 | Experimental | Requip; Four Ropinirole Implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropinirole oral product | Drug | oral immediate-release ropinirole |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24 Hours of Ropinirole | Area under the plasma drug concentration-time curve of ropinirole | 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. | 0-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24 Hours of N-despropyl Ropinirole | Area under the plasma drug concentration-time curve of N-despropyl ropinirole | 0-24 hours |
| AUC0-24 Hours of 7-hydroxy Ropinirole | Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Kate Beebe DeVarney | Titan Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando, Florida | Orlando | Florida | 32806 | United States | ||
| Farmington Hills, Michigan |
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Of 6 screened patients, 3 did not meet eligibility criteria for cohort assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Requip; One Ropinirole Implant |
| FG001 | Cohort 2 | Requip; Two Ropinirole Implants |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Requip IR [7-10 Days] |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2017 | Feb 1, 2023 |
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Subjects receive oral immediate release (IR) ropinirole for 7-10 days, and then are switched to ropinirole implant(s) for 12 weeks.
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| Ropinirole Implant | Drug | ropinirole hydrochloride/ethylene vinyl acetate |
|
| 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. | 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. | Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12 |
| 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 |
| Farmington Hills |
| Michigan |
| 48334 |
| United States |
| Kirkland, Washington | Kirkland | Washington | 98034 | United States |
| FG002 |
| Cohort 3 |
Requip; Three Ropinirole Implants |
| FG003 | Cohort 4 | Requip; Four Ropinirole Implants |
| COMPLETED |
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| NOT COMPLETED |
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| Ropinirole Implant 12 Weeks |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Requip; One Ropinirole Implant |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | Full Range | units on a scale |
| ||||||||||||||||
| 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 | Full Range | hours |
| ||||||||||||||||
| 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. | Mean | Full Range | hours |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC0-24 Hours of Ropinirole | Area under the plasma drug concentration-time curve of ropinirole | Subjects who received at least 1 ropinirole implant and for whom at least 1 PK parameter of interest can be calculated were to be included in this analysis. Analysis not performed due to insufficient representative samples from each cohort. | Posted | 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. | Subjects who received a least 1 ropinirole implant | Posted | Number | Events | 0-12 weeks |
|
| |||||||||||||||||
| Secondary | AUC0-24 Hours of N-despropyl Ropinirole | Area under the plasma drug concentration-time curve of N-despropyl ropinirole | Subjects who received at least 1 ropinirole implant and for whom at least 1 PK parameter of interest can be calculated were to be included in this analysis. Analysis not performed due to insufficient representative samples from each cohort. | Posted | 0-24 hours |
|
| |||||||||||||||||||
| Secondary | AUC0-24 Hours of 7-hydroxy Ropinirole | Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole | Subjects who received at least 1 ropinirole implant and for whom at least 1 PK parameter of interest can be calculated were to be included in this analysis. Analysis not performed due to insufficient representative samples from each cohort. | Posted | 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. | Subjects who receive at least 1 ropinirole implant and complete at least 1 post-baseline efficacy assessment. Three subjects were in the analysis population at Week 4. Two subjects were in the analysis population at Weeks 8 and 12. | Posted | Mean | Standard Error | units on a scale | 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. | Subjects who receive at least 1 ropinirole implant and complete at least 1 post-baseline efficacy assessment. Three subjects were in the analysis population for Weeks 1-6. Two subjects were in the analysis population for Weeks 8-12. | Posted | Mean | Standard Error | hours | 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 | Subjects who receive at least 1 ropinirole implant and complete at least 1 post-baseline efficacy assessment. Three subjects were in the analysis population for Weeks 1-6. Two subjects were in the analysis population for Weeks 8-12. | Posted | Mean | Standard Error | hours | Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12 |
|
|
From signing of the ICF until 30 days following study drug treatment discontinuation, up to 22 weeks.
Subjects assessed for AEs at every visit, routine collection of safety labs, and spontaneous self-reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Requip; One Ropinirole Implant | 0 | 3 | 0 | 3 | 2 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site reaction | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Freezing phenomenon | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
This was a first-in-human study of ropinirole implants. The trial was terminated early at the request of the Sponsor, not for reasons of safety or efficacy.
The Sponsor has rights to first publication of results unless waived by Sponsor. PIs may publish following Sponsor first publication or 18 months after conclusion, abandonment or termination of study. Sponsor to review proposed publications prior to public release and can embargo results for up to 60 days from the time submitted to the Sponsor for review and may remove any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Beebe DeVarney, PhD | Titan Pharmaceuticals, Inc. | 650-244-4990 | medinfo@titanpharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2018 | Feb 1, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020734 | Parkinsonian Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D009422 | Nervous System Diseases |
| D000080874 | Synucleinopathies |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C046649 | ropinirole |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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