Parkinson DiseasePhase 1NCT03496870
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.
A Phase 1 study testing Opicapone and Carbidopa Levodopa in people with Parkinson Disease, run by Neurocrine Biosciences at 3 sites in United States.
Trial summary
This is a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of opicapone when administered orally once daily for 14 days as adjunctive therapy to carbidopa/levodopa in subjects with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Opicapone and Carbidopa Levodopa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Feb 2018to 2 Jul 2018
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a clinical diagnosis of idiopathic Parkinson's Disease (PD) for at least 3 years with clear improvement with levodopa treatment
- Be at a stable dose of maintenance medication(s) for PD, including stable doses of CD/LD
- Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
- Have a body mass index (BMI) of 18 to 40 kg/m2
- Have a modified Hoehn and Yahr stage of ≤4 in the OFF state
- Be able to tolerate an overnight period of 12 hours without CD/LD
- Be in good general health and expected to complete the clinical study as designed
Who cannot join
- Are currently pregnant or breastfeeding
- More than 2 alcoholic beverages daily or more than 14 alcoholic beverages weekly within 7 days of Day -1 or consume any alcohol within 48 hours of Day -1.
- Have motor fluctuations during the day (ie, effect of levodopa "wearing off" or having unpredictable "off" periods), or severe or intolerable levodopa-induced dyskinesia
- Have had previous exposure to opicapone, or have an allergy, hypersensitivity, or intolerance to opicapone or other COMT inhibitor.
- Have a history of a medical condition or surgical procedure that might interfere with absorption or metabolism.
- Have a known history of neuroleptic malignant syndrome
Show all 11Show fewer
- Have an unstable medical condition or chronic disease
- Have taken certain prohibited medications within 28 days of Day -1.
- Have a known or suspected diagnosis of AIDS, or have tested seropositive for HIV
- Have hepatitis A or B
- Have a significant risk of suicidal or violent behavior
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Neurocrine Clinical Site
Farmington Hills, Michigan, 48334
Neurocrine Clinical Site
Glendale, California, 91206
Neurocrine Clinical Site
Long Beach, California, 90806
About this study
Official title: A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease
This is a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of opicapone when administered orally once daily for 14 days as adjunctive therapy to carbidopa/levodopa in subjects with Parkinson's disease.
- Conditions
- Parkinson Disease
- Being tested
- Opicapone, Carbidopa Levodopa
- 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 BIA 9-1067
catechol-O-methyltransferase (COMT) inhibitor
Carbidopa LevodopaDrug
Also called Sinemet
Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Opicapone once daily with Carbidopa/Levodopa | Experimental | Opicapone administered once daily for 14 days; carbidopa/levodopa administered at set frequency on Study Days 1, 2 \& 15 Receives: Drug: Opicapone; Drug: Carbidopa Levodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-24)
Area under the plasma concentration versus time curve from 0 to 24 hours for analytes with quantifiable concentrations at 24 hours postdose
Measured: up to 19 days
Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-tlast)
Area under the plasma concentration versus time curve from 0 hour to the time of the last measurable concentration for analytes below the limit of quantification at 24 hours postdose
Measured: up to 19 days
Pharmacokinetic evaluation of opicapone and its metabolites: Maximum plasma concentration (Cmax)
Maximum plasma concentration
Measured: up to 19 days
Pharmacokinetic evaluation of opicapone and its metabolites: Time to maximum plasma concentration (tmax)
Time to maximum plasma concentration
Measured: up to 19 days
Pharmacokinetic evaluation of levodopa following administration of opicapone: area under the curve (AUC 0-tlast)
Area under the plasma concentration versus time curve from 0 hours to time before next levodopa dose
Measured: up to 15 days
Pharmacokinetic evaluation of levodopa following administration of opicapone: maximum plasma concentration (cmax)
Maximum plasma concentration
Measured: up to 15 days
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Number of participants with reported adverse events after study treatment.
Measured: up to 19 days
Pharmacodynamic evaluation of opicapone on S-COMT activity
Maximum inhibition of S-COMT activity.
Measured: up to 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start8 Feb 2018
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496870
- Sponsor's protocol ID
- NBI-OPC-1706
- Status last verified
- Sep 2018
- First submitted
- 1 Mar 2018
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03496870
- Acronym / sponsor ID
- NBI-OPC-1706
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 12 Apr 2018 (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 a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of opicapone when administered orally once daily for 14 days as adjunctive therapy to carbidopa/levodopa in subjects with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opicapone once daily with Carbidopa/Levodopa | Experimental | Drug: Opicapone, Drug: Carbidopa LevodopaOpicapone administered once daily for 14 days; carbidopa/levodopa administered at set frequency on Study Days 1, 2 \& 15 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a clinical diagnosis of idiopathic Parkinson's Disease (PD) for at least 3 years with clear improvement with levodopa treatment
- Be at a stable dose of maintenance medication(s) for PD, including stable doses of CD/LD
- Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
- Have a body mass index (BMI) of 18 to 40 kg/m2
- Have a modified Hoehn and Yahr stage of ≤4 in the OFF state
Key exclusion criteria (11 listed)
- Are currently pregnant or breastfeeding
- More than 2 alcoholic beverages daily or more than 14 alcoholic beverages weekly within 7 days of Day -1 or consume any alcohol within 48 hours of Day -1.
- Have motor fluctuations during the day (ie, effect of levodopa "wearing off" or having unpredictable "off" periods), or severe or intolerable levodopa-induced dyskinesia
- Have had previous exposure to opicapone, or have an allergy, hypersensitivity, or intolerance to opicapone or other COMT inhibitor.
- Have a history of a medical condition or surgical procedure that might interfere with absorption or metabolism.
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: BIA 9-1067catechol-O-methyltransferase (COMT) inhibitor | Drug | Opicapone once daily with Carbidopa/Levodopa |
| Carbidopa LevodopaAlso: SinemetLevodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor | Drug | Opicapone once daily with Carbidopa/Levodopa |
Primary outcome
Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-24)
Time frame: up to 19 days
Area under the plasma concentration versus time curve from 0 to 24 hours for analytes with quantifiable concentrations at 24 hours postdose
Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-tlast)
Time frame: up to 19 days
Area under the plasma concentration versus time curve from 0 hour to the time of the last measurable concentration for analytes below the limit of quantification at 24 hours postdose
Pharmacokinetic evaluation of opicapone and its metabolites: Maximum plasma concentration (Cmax)
Time frame: up to 19 days
Maximum plasma concentration
Pharmacokinetic evaluation of opicapone and its metabolites: Time to maximum plasma concentration (tmax)
Time frame: up to 19 days
Time to maximum plasma concentration
Pharmacokinetic evaluation of levodopa following administration of opicapone: area under the curve (AUC 0-tlast)
Time frame: up to 15 days
Area under the plasma concentration versus time curve from 0 hours to time before next levodopa dose
Pharmacokinetic evaluation of levodopa following administration of opicapone: maximum plasma concentration (cmax)
Time frame: up to 15 days
Maximum plasma concentration
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Time frame: up to 19 days
Pharmacodynamic evaluation of opicapone on S-COMT activity
Time frame: up to 19 days
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 22 Mar 2019.
- 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.
Chief Medical Officer study director
Chief Medical Officer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Opicapone and Carbidopa Levodopa in people with Parkinson Disease, run by Neurocrine Biosciences 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 7 inclusion and 11 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 22 Mar 2019. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-24) (time frame: up to 19 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2019.