Parkinson DiseasePhase 1/2NCT03250117

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

A Phase 1/2 study testing Ropinirole oral product and Ropinirole Implant in people with Parkinson Disease, run by Titan Pharmaceuticals at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Parkinson Disease
What is being tested?: Ropinirole oral product and Ropinirole Implant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 3 sitesUnited States
Study dates: 10 Oct 2017to 22 May 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Farmington Hills, Michigan
Farmington Hills, Michigan, 48334
Kirkland, Washington
Kirkland, Washington, 98034
Orlando, Florida
Orlando, Florida, 32806

Other trials in United States

About this study

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

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.

Conditions: Parkinson Disease
Being tested: Ropinirole oral product, Ropinirole Implant
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
Medical subject headings: Parkinson Disease, Dyskinesias, Movement Disorders, Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ropinirole oral productDrug
Also called Requip
oral immediate-release ropinirole
Ropinirole ImplantDrug
ropinirole hydrochloride/ethylene vinyl acetate

Study groups in NCT03250117
Study group	Role	What they receive
Cohort 1	Experimental	Requip; One Ropinirole Implant Receives: Drug: Ropinirole oral product; Drug: Ropinirole Implant
Cohort 2	Experimental	Requip; Two Ropinirole Implants Receives: Drug: Ropinirole oral product; Drug: Ropinirole Implant
Cohort 3	Experimental	Requip; Three Ropinirole Implants Receives: Drug: Ropinirole oral product; Drug: Ropinirole Implant
Cohort 4	Experimental	Requip; Four Ropinirole Implants Receives: Drug: Ropinirole oral product; Drug: Ropinirole Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC0-24 Hours of Ropinirole
Area under the plasma drug concentration-time curve of ropinirole
Measured: 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.
Measured: 0-12 weeks

Secondary outcomes (5)

AUC0-24 Hours of N-despropyl Ropinirole
Area under the plasma drug concentration-time curve of N-despropyl ropinirole
Measured: 0-24 hours
AUC0-24 Hours of 7-hydroxy Ropinirole
Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 201722 May 2018

First posted15 Aug 2017
Study start10 Oct 2017
Primary completion22 May 2018
Study completion22 May 2018

Why it stopped: This study was terminated for reasons not related to efficacy or safety

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
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)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03250117
Sponsor's protocol ID: ROP-001
Status last verified: Apr 2023
First submitted: 11 Aug 2017
Last updated: 6 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03250117
Acronym / sponsor ID: ROP-001
Conditions: Parkinson Disease
Keywords: Parkinson Disease, Dyskinesia, ropinirole, implant, ProNeura, movement disorders, dopamine agonist, extended-release
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated for reasons not related to efficacy or safety
Enrolment: 6 participants (actual)
Lead sponsor: Titan PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 10 Oct 2017 (actual)
Primary completion: 22 May 2018 (actual)
Study completion: 22 May 2018 (actual)
First posted: 15 Aug 2017 (actual)
Results: Posted 6 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4
Model description: Subjects receive oral immediate release (IR) ropinirole for 7-10 days, and then are switched to ropinirole implant(s) for 12 weeks.

Arm	Type	Receives
Cohort 1	Experimental	Drug: Ropinirole oral product, Drug: Ropinirole ImplantRequip; One Ropinirole Implant
Cohort 2	Experimental	Drug: Ropinirole oral product, Drug: Ropinirole ImplantRequip; Two Ropinirole Implants
Cohort 3	Experimental	Drug: Ropinirole oral product, Drug: Ropinirole ImplantRequip; Three Ropinirole Implants
Cohort 4	Experimental	Drug: Ropinirole oral product, Drug: Ropinirole ImplantRequip; Four Ropinirole Implants

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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 (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ropinirole oral productAlso: Requiporal immediate-release ropinirole	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4
Ropinirole Implantropinirole hydrochloride/ethylene vinyl acetate	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4

Primary outcome

AUC0-24 Hours of Ropinirole
Time frame: 0-24 hours
Area under the plasma drug concentration-time curve of ropinirole
Total Number of Adverse Events Across Participants
Time frame: 0-12 weeks
Safety and tolerability of ropinirole implant(s) presented as the total number of adverse events experienced by the analysis population.

5 secondary outcomes

AUC0-24 Hours of N-despropyl Ropinirole
Time frame: 0-24 hours
AUC0-24 Hours of 7-hydroxy Ropinirole
Time frame: 0-24 hours
Mean Change From Baseline in MDS-UPDRS Total Score
Time frame: Baseline and Weeks 4, 8 and 12
Mean Change From Baseline of Awake Time "On"
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12
Mean Change From Baseline of Awake Time "Off"
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12

Results and safety

Results posted to the registry on 6 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	3	3
Cohort 2	0	0
Cohort 3	0	0
Cohort 4	0	0

Primary outcome: AUC0-24 Hours of Ropinirole

Time frame: 0-24 hours

Population analysed: 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 outcome: Total Number of Adverse Events Across Participants

Time frame: 0-12 weeks. Number. Unit: Events

Measure	Cohort 1 n = 3
Value	4

Population analysed: Subjects who received a least 1 ropinirole implant

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of the ICF until 30 days following study drug treatment discontinuation, up to 22 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. Kate Beebe DeVarney study director

Titan Pharmaceuticals

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ropinirole oral product and Ropinirole Implant in people with Parkinson Disease, run by Titan Pharmaceuticals at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-24 Hours of Ropinirole (time frame: 0-24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03250117.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.