Trial · NCT03250117
Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
NCT03250117, Phase 1, Phase 2, Terminated, Titan Pharmaceuticals; results first posted 2023-05-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole. Trials, record NCT03250117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03250117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
- NCT number
- NCT03250117
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Titan Pharmaceuticals
- Conditions
- Parkinson Disease
- Interventions
- Ropinirole oral product, Ropinirole Implant
- First posted
- 2017-08-15
- Last updated
- 2023-05-06
- Results first posted
- 2023-05-06
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AUC0-24 Hours of Ropinirole | 0-24 hours | Area under the plasma drug concentration-time curve of ropinirole |
| Primary | 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 | AUC0-24 Hours of N-despropyl Ropinirole | 0-24 hours | Area under the plasma drug concentration-time curve of N-despropyl ropinirole |
| Secondary | AUC0-24 Hours of 7-hydroxy Ropinirole | 0-24 hours | Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | AUC0-24 Hours of Ropinirole | 0-24 hours | 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. | ||
| PRIMARY | Total Number of Adverse Events Across Participants | 0-12 weeks | Subjects who received a least 1 ropinirole implant | Events | NUMBER |
| SECONDARY | AUC0-24 Hours of N-despropyl Ropinirole | 0-24 hours | 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. | ||
| SECONDARY | AUC0-24 Hours of 7-hydroxy Ropinirole | 0-24 hours | 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. | ||
| SECONDARY | Mean Change From Baseline in MDS-UPDRS Total Score | Baseline and Weeks 4, 8 and 12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline of Awake Time On | Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12 | 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. | hours | MEAN |
| SECONDARY | Mean Change From Baseline of Awake Time Off | Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12 | 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. | hours | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Number of Adverse Events Across Participants | Cohort 1 | 4 | Events | ||
| Mean Change From Baseline in MDS-UPDRS Total Score | Cohort 1 | Week 4 | 4.0 | Standard Error 3.28 | units on a scale |
| Mean Change From Baseline in MDS-UPDRS Total Score | Cohort 1 | Week 8 | 10.6 | Standard Error 13.42 | units on a scale |
| Mean Change From Baseline in MDS-UPDRS Total Score | Cohort 1 | Week 12 | 7.3 | Standard Error 4.04 | units on a scale |
| Mean Change From Baseline of Awake Time On | Cohort 1 | Week 1 | 0.80 | Standard Error 1.078 | hours |
| Mean Change From Baseline of Awake Time On | Cohort 1 | Week 2 | 1.11 | Standard Error 0.457 | hours |
| Mean Change From Baseline of Awake Time On | Cohort 1 | Week 3 | 1.70 | Standard Error 0.908 | hours |
| Mean Change From Baseline of Awake Time On | Cohort 1 | Week 4 | 0.77 | Standard Error 0.608 | hours |
| Mean Change From Baseline of Awake Time On | Cohort 1 | Week 6 | 0.66 | Standard Error 1.175 | hours |
| Mean Change From Baseline of Awake Time On | Cohort 1 | Week 8 | 0.11 | Standard Error 1.344 | hours |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Requip IR [7-10 Days] | STARTED | Cohort 1 | 3 | |
| Requip IR [7-10 Days] | STARTED | Cohort 2 | 0 | |
| Requip IR [7-10 Days] | STARTED | Cohort 3 | 0 | |
| Requip IR [7-10 Days] | STARTED | Cohort 4 | 0 | |
| Requip IR [7-10 Days] | COMPLETED | Cohort 1 | 3 | |
| Requip IR [7-10 Days] | COMPLETED | Cohort 2 | 0 | |
| Requip IR [7-10 Days] | COMPLETED | Cohort 3 | 0 | |
| Requip IR [7-10 Days] | COMPLETED | Cohort 4 | 0 | |
| Requip IR [7-10 Days] | NOT COMPLETED | Cohort 1 | 0 | |
| Requip IR [7-10 Days] | NOT COMPLETED | Cohort 2 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Implant site reaction | General disorders | Cohort 1 | 1 | 3 | 1 |
| other | Freezing phenomenon | Nervous system disorders | Cohort 1 | 1 | 3 | 1 |
| other | Affect lability | Psychiatric disorders | Cohort 1 | 1 | 3 | 1 |
| other | Hallucination, visual | Psychiatric disorders | Cohort 1 | 1 | 3 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 0 | 3 |
| Total, other adverse events | Cohort 1 | 2 | 3 |
| Total, serious adverse events | Cohort 1 | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03250117
GET https://conductscience.org/api/trials/v1/NCT03250117/flow?page=2