A Phase 1/2 interventional study of Ropinirole oral product and Ropinirole Implant in Parkinson Disease, sponsored by Titan Pharmaceuticals. Terminated at 3 sites in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Titan Pharmaceuticals · Phase 1/2, Interventional, and Treatment
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Among 12 studies testing ropinirole in Parkinson Disease — none open to participants now, none under way, none of them phase 3. ropinirole · Parkinson Disease.
Among the 12 studies testing ropinirole in Parkinson Disease, this one is the 12th largest by enrollment, is the only one that started in 2017, is the only one in phase 1/2, and was the 12th registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →None of the 12 studies testing ropinirole in Parkinson Disease is open now. The open studies under Parkinson Disease, anywhere →
ropinirole: first FDA approval 1997 (REQUIP). What it is approved for, and how studies give it, is on its page →
Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.
This study: 30 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 3 · Phase 4 4
First in 2001; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 108 across the 12 interventional studies. Of the 11 that completed or were terminated, 4 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 12 have an industry lead sponsor. The 7 most frequent:
Titan Pharmaceuticals is the lead sponsor of 13 studies on the registry; none are open to participants now.
Titan Pharmaceuticals has 1 study filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies testing ropinirole in Parkinson Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Requip; One Ropinirole Implant
Drug: Ropinirole oral product · Drug: Ropinirole Implant
Requip; Two Ropinirole Implants
Drug: Ropinirole oral product · Drug: Ropinirole Implant
Requip; Three Ropinirole Implants
Drug: Ropinirole oral product · Drug: Ropinirole Implant
Requip; Four Ropinirole Implants
Drug: Ropinirole oral product · Drug: Ropinirole Implant
oral immediate-release ropinirole
Also known as: Requip
ropinirole hydrochloride/ethylene vinyl acetate
AUC0-24 Hours of Ropinirole
Area under the plasma drug concentration-time curve of ropinirole
Time frame: 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.
Time frame: 0-12 weeks
AUC0-24 Hours of N-despropyl Ropinirole
Area under the plasma drug concentration-time curve of N-despropyl ropinirole
Time frame: 0-24 hours
AUC0-24 Hours of 7-hydroxy Ropinirole
Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12
| Milestone | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Started | 3 | 0 | 0 | 0 |
| Completed | 3 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Started | 3 | 0 | 0 | 0 |
| Completed | 2 | 0 | 0 | 0 |
| Not completed | 1 | 0 | 0 | 0 |
| Withdrew: At request of sponsor, regulatory agencies, or the irb | 1 | 0 | 0 | 0 |
Area under the plasma drug concentration-time curve of ropinirole
No measurements were reported for this outcome.
Safety and tolerability of ropinirole implant(s) presented as the total number of adverse events experienced by the analysis population.
| Events | Cohort 1 |
|---|---|
| Total Number of Adverse Events Across Participants | 4 |
Area under the plasma drug concentration-time curve of N-despropyl ropinirole
No measurements were reported for this outcome.
Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole
No measurements were reported for this outcome.
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.
| units on a scale | Cohort 1 |
|---|---|
| Week 4 | 4.0 ± 3.28 |
| Week 8 | 10.6 ± 13.42 |
| Week 12 | 7.3 ± 4.04 |
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.
| hours | Cohort 1 |
|---|---|
| Week 1 | 0.80 ± 1.078 |
| Week 2 | 1.11 ± 0.457 |
| Week 3 | 1.70 ± 0.908 |
| Week 4 | 0.77 ± 0.608 |
| Week 6 | 0.66 ± 1.175 |
| Week 8 | 0.11 ± 1.344 |
| Week 10 | 0.93 ± 0.756 |
| Week 12 | 0.58 ± 1.101 |
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
| hours | Cohort 1 |
|---|---|
| Week 1 | -1.36 ± 0.974 |
| Week 2 | -1.67 ± 0.921 |
| Week 3 | -2.26 ± 1.062 |
| Week 4 | -1.33 ± 1.094 |
| Week 6 | -1.22 ± 1.506 |
| Week 8 | -0.83 ± 2.068 |
| Week 10 | -1.77 ± 1.598 |
| Week 12 | -1.43 ± 1.943 |
Collected over From signing of the ICF until 30 days following study drug treatment discontinuation, up to 22 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Event | Cohort 1 |
|---|---|
| Implant site reactionGeneral disorders | 1/3 |
| Freezing phenomenonNervous system disorders | 1/3 |
| Affect labilityPsychiatric disorders | 1/3 |
| Hallucination, visualPsychiatric disorders | 1/3 |
| Age, Continuous(years) | Cohort 1 |
|---|---|
| Mean | 52.7 (47 to 58) |
| Sex: Female, Male(Participants) | Cohort 1 |
|---|---|
| Female | 1 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| MDS-UPDRS Total Score(units on a scale) | Cohort 1 |
|---|---|
| Mean | 60.7 (23 to 97) |
| Awake Time "On"(hours) | Cohort 1 |
|---|---|
| Mean | 11.54 (9.9 to 14.3) |
| Awake Time "Off"(hours) | Cohort 1 |
|---|---|
| Mean | 5.02 (3.4 to 6.1) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in May 2018, 7 months.
Results were first posted in May 2023, 4 years 11 months after primary completion. A results delay was requested in Jan 2020.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropinirole
Titan Pharmaceuticals