Parkinson DiseaseOPTI-ONNCT04787965
Opicapone Treatment Initiation Open-Label Study
An observational study of Parkinson Disease, run by Neurocrine Biosciences at 6 sites in United States.
Trial summary
This is an observational study to describe the treatment patterns and clinical outcomes observed with use of ONGENTYS as adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients experiencing "off" episodes with motor fluctuations Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Opicapone
- Type of treatment
- Pill or oral medicine
- How many people
- 239 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Mar 2021to 4 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease patients experiencing "off" episodes with motor fluctuations, who are currently being treated by a neurologist and require adjunctive treatment to levodopa/carbidopa
Who may be able to join
- Must be able to complete electronic patient-reported outcome instruments
- Parkinson's disease patients experiencing "off" episodes
- Patient receiving concomitant levodopa/carbidopa, and as deemed appropriate by the physician, newly initiating ONGENTYS as adjunctive treatment
Who cannot join
- Patient is not cognitively able to complete the study requirements
- Patient is not able to complete the study duration of 6 months
- History of moderate or severe hepatic impairment
- Patient has end-stage renal disease
- Concomitant use of non-selective monoamine oxidase (MAO) inhibitor or catechol-O-methyltransferase (COMT) inhibitors (patients entering study may switch from other COMT inhibitors to ONGENTYS)
- History of pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms
- Currently enrolled in an interventional clinical trial
- Currently or previously received ONGENTYS
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Neurocrine clinical site
Auburn, Washington, 98002
Neurocrine clinical site
Christiansburg, Virginia, 24073
Neurocrine clinical site
Crab Orchard, West Virginia, 25827
Neurocrine clinical site
Los Gatos, California, 95032
Neurocrine clinical site
Memphis, Tennessee, 38157
Neurocrine clinical site
Norfolk, Virginia, 68134
About this study
This is an observational study to describe the treatment patterns and clinical outcomes observed with use of ONGENTYS as adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients experiencing "off" episodes with motor fluctuations
- Conditions
- Parkinson Disease
- Being tested
- Opicapone
- Keywords
- Parkinson's disease (PD), Levodopa, Carbidopa, Motor Fluctuations, Non-Motor Fluctuations, Adjunctive treatment, COMT inhibitor
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpicaponeDrug
Also called ONGENTYS
Opicapone as adjunctive treatment to levodopa/carbidopa over a 6-month period
| Study group | Role | What they receive |
|---|---|---|
| ONGENTYS | Opicapone 50 mg capsule once daily for 6 months Receives: Drug: Opicapone |
What is being measured
The primary outcome is the main question the study is designed to answer.
ONGENTYS treatment patterns
Reason for initiating treatment and discontinuation
Measured: 6 months
Secondary outcomes (6)
PD Status
PD Status Questionnaire
Measured: 6 months
CGI-C
Clinical Global Impression of Change Scale
Measured: 6 months
MDS-UPDRS Parts I, II, and IV
Movement Disorder Society-Unified Parkinson's Disease Rating Scale
Measured: 6 months
PDQ-8
Parkinson's Disease Questionnaire-8
Measured: 6 months
PGI-C
Patient Global Impression of Change Scale
Measured: 6 months
NoMoFa
Non-Motor Fluctuation Assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Mar 2021
- Primary completion4 Aug 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga Klepitskaya, MD, FAAN, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787965
- Sponsor's protocol ID
- NBI-OPC-PD4006
- Acronym
- OPTI-ON
- Status last verified
- Nov 2022
- First submitted
- 4 Mar 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-Silva P; Bi-Park 1 investigators. Opicapone as an adjunct to levodopa in patients with Parkinson's disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol. 2016 Feb;15(2):154-165. doi: 10.1016/S1474-4422(15)00336-1. Epub 2015 Dec 23.
PubMed 26725544Lees AJ, Ferreira J, Rascol O, Poewe W, Rocha JF, McCrory M, Soares-da-Silva P; BIPARK-2 Study Investigators. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol. 2017 Feb 1;74(2):197-206. doi: 10.1001/jamaneurol.2016.4703.
PubMed 28027332
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opicapone Treatment Initiation Open-Label Study
- ClinicalTrials.gov ID
- NCT04787965
- Acronym / sponsor ID
- OPTI-ON / NBI-OPC-PD4006
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease (PD), Levodopa, Carbidopa, Motor Fluctuations, Non-Motor Fluctuations, Adjunctive treatment, COMT inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study to describe the treatment patterns and clinical outcomes observed with use of ONGENTYS as adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients experiencing "off" episodes with motor fluctuations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONGENTYS | – | Drug: OpicaponeOpicapone 50 mg capsule once daily for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patients experiencing "off" episodes with motor fluctuations, who are currently being treated by a neurologist and require adjunctive treatment to levodopa/carbidopa
Key inclusion criteria (3 listed)
- Must be able to complete electronic patient-reported outcome instruments
- Parkinson's disease patients experiencing "off" episodes
- Patient receiving concomitant levodopa/carbidopa, and as deemed appropriate by the physician, newly initiating ONGENTYS as adjunctive treatment
Key exclusion criteria (8 listed)
- Patient is not cognitively able to complete the study requirements
- Patient is not able to complete the study duration of 6 months
- History of moderate or severe hepatic impairment
- Patient has end-stage renal disease
- Concomitant use of non-selective monoamine oxidase (MAO) inhibitor or catechol-O-methyltransferase (COMT) inhibitors (patients entering study may switch from other COMT inhibitors to ONGENTYS)
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 |
|---|---|---|
| OpicaponeAlso: ONGENTYSOpicapone as adjunctive treatment to levodopa/carbidopa over a 6-month period | Drug | ONGENTYS |
Primary outcome
ONGENTYS treatment patterns
Time frame: 6 months
Reason for initiating treatment and discontinuation
6 secondary outcomes
PD Status
Time frame: 6 months
CGI-C
Time frame: 6 months
MDS-UPDRS Parts I, II, and IV
Time frame: 6 months
PDQ-8
Time frame: 6 months
PGI-C
Time frame: 6 months
NoMoFa
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Background: PubMed 26725544Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-Silva P; Bi-Park 1 investigators. Opicapone as an adjunct to levodopa in patients with Parkinson's disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol. 2016 Feb;15(2):154-165. doi: 10.1016/S1474-4422(15)00336-1. Epub 2015 Dec 23.
- Background: PubMed 28027332Lees AJ, Ferreira J, Rascol O, Poewe W, Rocha JF, McCrory M, Soares-da-Silva P; BIPARK-2 Study Investigators. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol. 2017 Feb 1;74(2):197-206. doi: 10.1001/jamaneurol.2016.4703.
- Individual participant dataSharing planned: No
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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.
Olga Klepitskaya, MD, FAAN study director
Neurocrine Biosciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Neurocrine Biosciences at 6 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 3 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: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ONGENTYS treatment patterns (time frame: 6 months). 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 NCT04787965, which also lists 2 linked publications.
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 28 Nov 2022.