Parkinson's DiseasePhase 2NCT01568034

A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067

A Phase 2 study testing BIA 9-1067, Levodopa/Carbidopa and Levodopa/Benzerazide in people with Parkinson's Disease, run by Bial - Portela C S.A. at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients. Read more about this study

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Parkinson's Disease
What is being tested?: BIA 9-1067, Levodopa/Carbidopa and Levodopa/Benzerazide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 3 sitesin 3 countries
Study dates: Apr 2009to Feb 2010
Phase: Phase 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female of non-childbearing potential (by reason of surgery or postmenopausal);
Aged between 30 and 75 years, inclusive;
A diagnosis of PD according to the UK PDS Brain Bank diagnostic criteria (bradykinesia and at least one of the following: muscular rigidity, rest tremor and postural instability);
Predictable signs of end-of-dose deterioration despite "optimal" levodopa/carbidopa or levodopa/benserazide therapy;
Been treated with a stable regimen of 3 to 8 doses of standard release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide per day within at least 1 week prior to randomisation;
Modified Hoehn and Yahr stage of less than 5 in the off-state;

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Mean duration of OFF stage ≥ 1.5 h during waking hours (based on historical information);
Concomitant anti-Parkinsonian medication (other than apomorphine, entacapone or tolcapone) in stable doses for at least 4 weeks prior to randomisation;
Results of clinical laboratory tests acceptable by the investigator (not clinically significant for the well-being of the subject or for the purpose of the study);
Able and willing to give written informed consent.

Who cannot join

Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome);
Treated with levodopa/carbidopa or levodopa/benserazide in a 10:1 ratio, or with levodopa/carbidopa in a controlled-release formulation;
Treated with entacapone, tolcapone, neuroleptics, antidepressants (except serotonin-specific reuptake inhibitors or imipramines [desipramine, imipramine, clomipramine and amitriptyline]), monoamine oxidase inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day) or antiemetics (except domperidone) within 4 weeks prior to randomisation;
Treated with apomorphine within 7 days prior to randomisation;
Treated with any investigational product within 2 months prior to randomisation (or within 5 half-lives, whichever is longer);
A psychiatric or any medical condition that might place him/her at increased risk or interfere with assessments;

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Known hypersensitivity to any of the ingredients of the investigational products;
A history of abuse of alcohol, drugs or medications within the last 2 years;
A clinically relevant ECG abnormality;
A history or current evidence of heart disease, including but not limited to myocardial infarction, angina, congestive heart failure and cardiac arrhythmia;
Unstable concomitant disease being treated with changing doses of medication;
A history or current evidence of any relevant disease in the context of this study, i.e., with respect to the safety of the subject (e.g., hepatic or renal impairment) or related to the study conditions;
A test positive for the human immunodeficiency viruses (HIV) 1 or 2 antibodies, or hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb);
Donated blood or received blood or blood products within the 6 months prior to randomisation;
Pregnant, breast-feeding or of childbearing potential;
Other condition or circumstance that, in the opinion of the investigator, may compromise the subject's ability to comply with the study protocol.

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Portugal1 site

Department of Neurology-Hospital de Santa Maria-Faculty of Medicine, University of Lisbon
Lisbon, 1649-035

Other trials in Portugal

Romania1 site

Spitalul Clinic Colentina - Clinica de Neurologie
Bucharest, 020125

Other trials in Romania

Ukraine1 site

Department of Neurology- Hospital of the department of medical care of Ministry Internal Affairs of Ukraine
Kyiv, 04050

Other trials in Ukraine

About this study

Official title: A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor

Read the detailed description

This was a three-centre, double-blind, randomised, placebo-controlled, crossover study with four consecutive single-dose treatment periods in PD patients treated with immediate release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide

Conditions: Parkinson's Disease
Being tested: BIA 9-1067, Placebo, Levodopa/Carbidopa, Levodopa/Benzerazide
Keywords: Parkinson's Disease, BIA 9-1067
Medical subject headings: Parkinson Disease

What participants receive

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

BIA 9-1067Drug
Also called OPC, Opicapone
BIA 9-1067 - 25 mg single-dose
BIA 9-1067Drug
Also called OPC, Opicapone
BIA 9-1067 - 50 mg single-dose
BIA 9-1067Drug
Also called OPC, Opicapone
BIA 9-1067 - 100 mg single-dose
PlaceboDrug
Also called PLC
single-dose
Levodopa/CarbidopaDrug
Also called Sinemet
Levodopa 100 mg Carbidopa 25 mg
Levodopa/BenzerazideDrug
Also called Madopar®/Restex®
Levodopa 100 mg Benzerazide 25 mg

Study groups in NCT01568034
Study group	Role	What they receive
Treatment Sequence A	Experimental	Treatment Sequence A Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half Receives: Drug: BIA 9-1067; Drug: Placebo; Drug: Levodopa/Carbidopa; Drug: Levodopa/Benzerazide
Treatment Sequence B	Experimental	Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067 Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half Receives: Drug: BIA 9-1067; Drug: Placebo; Drug: Levodopa/Carbidopa; Drug: Levodopa/Benzerazide
Treatment Sequence C	Experimental	Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067 Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half Receives: Drug: BIA 9-1067; Drug: Placebo; Drug: Levodopa/Carbidopa; Drug: Levodopa/Benzerazide
Treatment Sequence D	Experimental	Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067 Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half Receives: Drug: BIA 9-1067; Drug: Placebo; Drug: Levodopa/Carbidopa; Drug: Levodopa/Benzerazide

What is being measured

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

Cmax - Maximum Plasma Concentration Day 3
Cmax - Maximum plasma concentration (ng/mL)
Measured: Day 3
Tmax = Time to Cmax Day 3
tmax = time to Cmax (values are median)
Measured: Day 3

Secondary outcomes (1)

AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)
AUC0-6 - area under the plasma concentration-time curve from time 0 to 6 hours post-dose (ng.h/mL)
Measured: Day 3

Timeline

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

Apr 2009Feb 2010

First posted2 Apr 2012 (estimated)
Study startApr 2009
Primary completionFeb 2010
Study completionFeb 2010

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's 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01568034
Sponsor's protocol ID: BIA-91067-201
Other IDs: 2008-003869-72, 2008
Status last verified: Dec 2014
First submitted: 29 Mar 2012
Last updated: 12 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor
ClinicalTrials.gov ID: NCT01568034
Acronym / sponsor ID: BIA-91067-201
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease, BIA 9-1067
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 2 Apr 2012 (estimated)
Results: Posted 12 Jan 2015

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Treatment Sequence A	Experimental	Drug: BIA 9-1067, Drug: Placebo, Drug: Levodopa/Carbidopa, Drug: Levodopa/BenzerazideTreatment Sequence A Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
Treatment Sequence B	Experimental	Drug: BIA 9-1067, Drug: Placebo, Drug: Levodopa/Carbidopa, Drug: Levodopa/BenzerazideTreatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067 Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
Treatment Sequence C	Experimental	Drug: BIA 9-1067, Drug: Placebo, Drug: Levodopa/Carbidopa, Drug: Levodopa/BenzerazideTreatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067 Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
Treatment Sequence D	Experimental	Drug: BIA 9-1067, Drug: Placebo, Drug: Levodopa/Carbidopa, Drug: Levodopa/BenzerazideTreatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067 Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female of non-childbearing potential (by reason of surgery or postmenopausal);
Aged between 30 and 75 years, inclusive;
A diagnosis of PD according to the UK PDS Brain Bank diagnostic criteria (bradykinesia and at least one of the following: muscular rigidity, rest tremor and postural instability);
Predictable signs of end-of-dose deterioration despite "optimal" levodopa/carbidopa or levodopa/benserazide therapy;
Been treated with a stable regimen of 3 to 8 doses of standard release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide per day within at least 1 week prior to randomisation;

Key exclusion criteria (16 listed)

Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome);
Treated with levodopa/carbidopa or levodopa/benserazide in a 10:1 ratio, or with levodopa/carbidopa in a controlled-release formulation;
Treated with entacapone, tolcapone, neuroleptics, antidepressants (except serotonin-specific reuptake inhibitors or imipramines [desipramine, imipramine, clomipramine and amitriptyline]), monoamine oxidase inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day) or antiemetics (except domperidone) within 4 weeks prior to randomisation;
Treated with apomorphine within 7 days prior to randomisation;
Treated with any investigational product within 2 months prior to randomisation (or within 5 half-lives, whichever is longer);

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
BIA 9-1067Also: OPC, OpicaponeBIA 9-1067 - 25 mg single-dose	Drug	Treatment Sequence A, Treatment Sequence B, Treatment Sequence C, Treatment Sequence D
BIA 9-1067Also: OPC, OpicaponeBIA 9-1067 - 50 mg single-dose	Drug	Treatment Sequence A, Treatment Sequence B, Treatment Sequence C, Treatment Sequence D
BIA 9-1067Also: OPC, OpicaponeBIA 9-1067 - 100 mg single-dose	Drug	Treatment Sequence A, Treatment Sequence B, Treatment Sequence C, Treatment Sequence D
PlaceboAlso: PLCsingle-dose	Drug	Treatment Sequence A, Treatment Sequence B, Treatment Sequence C, Treatment Sequence D
Levodopa/CarbidopaAlso: SinemetLevodopa 100 mg Carbidopa 25 mg	Drug	Treatment Sequence A, Treatment Sequence B, Treatment Sequence C, Treatment Sequence D
Levodopa/BenzerazideAlso: Madopar®/Restex®Levodopa 100 mg Benzerazide 25 mg	Drug	Treatment Sequence A, Treatment Sequence B, Treatment Sequence C, Treatment Sequence D

Primary outcome

Cmax - Maximum Plasma Concentration Day 3
Time frame: Day 3
Cmax - Maximum plasma concentration (ng/mL)
Tmax = Time to Cmax Day 3
Time frame: Day 3
tmax = time to Cmax (values are median)

1 secondary outcome

AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)
Time frame: Day 3

Results and safety

Results posted to the registry on 12 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence A	2	1
Treatment Sequence B	2	2
Treatment Sequence C	3	3
Treatment Sequence D	3	3

Primary outcome: Cmax - Maximum Plasma Concentration Day 3

Time frame: Day 3. Mean (Standard Deviation). Unit: ng/ml

Measure	Placebo n = 9	BIA 9-1067 25 mg n = 10	BIA 9-1067 50 mg n = 10	BIA 9-1067 100 mg n = 10
Cmax (levodopa)	2103 (48.4)	2112 (49.6)	2366 (44.0)	2657 (32.5)
Cmax (3-OMD)	3996 (50.5)	4193 (42.4)	4284 (49.2)	4085 (60.4)
Cmax (BIA 9-067)	NA (NA)	320 (57.2)	590 (41.5)	816 (35.5)

Primary outcome: Tmax = Time to Cmax Day 3

Time frame: Day 3. Median (Full Range). Unit: hours

Measure	Placebo n = 9	BIA 9-1067 25 mg n = 10	BIA 9-1067 50 mg n = 10	BIA 9-1067 100 mg n = 10
Tmax (levodopa)	0.5 (0.5 to 1.5)	1.0 (0.5 to 2.0)	0.5 (0.5 to 2.0)	0.5 (0.5 to 1.5)
Tmax (3-OMD)	2.00 (0.0 to 3.0)	1.75 (0.0 to 4.0)	2.50 (0.0 to 4.0)	1.75 (1.0 to 6.0)
Tmax (BIA 9-067)	NA (NA to NA)	2.00 (0.5 to 3.0)	2.00 (1.0 to 6.0)	2.00 (1.0 to 4.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 10 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
25 mg BIA 9-1067	0 of 10 (0%)	5 of 10 (50%)	Not reported
50 mg BIA 9-1067	0 of 10 (0%)	6 of 10 (60%)	Not reported
100 mg BIA 9-1067	0 of 10 (0%)	7 of 10 (70%)	Not reported
Placebo	0 of 9 (0%)	3 of 9 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Parkinson's Disease

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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.

Joaquim Ferreira, MD, PhD principal investigator

Hospital de Santa Maria, Lisbon

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIA 9-1067, Levodopa/Carbidopa and Levodopa/Benzerazide in people with Parkinson's Disease, run by Bial - Portela C S.A. at 3 sites in 3 countries.

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 10 inclusion and 16 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 12 Jan 2015. 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 Portugal, Romania, Ukraine. 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 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 12 Jan 2015). 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?

Cmax - Maximum Plasma Concentration Day 3 (time frame: Day 3). 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 NCT01568034.

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 12 Jan 2015.