Parkinson's DiseasePhase 2NCT01568047

Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients

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 7 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated with levodopa/dopa-decarboxylase inhibitor. Read more about this study

Who is it for?: Ages 30 years and older
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: 40 participants
Where: 7 sitesin 2 countries
Study dates: Feb 2010to Jun 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At screening (admission to the baseline period):
Male or female of non-childbearing potential (by reason of surgery or postmenopausal);
Age ≥ 30 years;
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;
Modified Hoehn and Yahr stage of less than 5 in the "off" state; mean duration of "off" state ≥ 1.5 h during waking hours (based on historical information);

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Results of clinical laboratory tests acceptable by the investigator (not clinically significant for the well-being of the patient or for the purpose of the study);
Able and willing to give written informed consent.
At randomisation (completion of the baseline period):
Been treated with a stable regimen of 3 to 8 doses per day of standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) for at least 1 week prior to randomisation;
Mean duration of "off" state ≥ 1.5 h during waking hours (average of recordings of last 3 evaluable days on patient's diary);
Concomitant anti-Parkinsonian medication (other than apomorphine, entacapone or tolcapone) in stable doses for at least 4 weeks prior to admission.

Who cannot join

At screening (admission to the baseline period):
Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome);
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 2 weeks prior to admission;
Treated with any investigational product within 1 month prior to admission (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;
Known hypersensitivity to any of the ingredients of the investigational products;

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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 patient (e.g., hepatic impairment) or related to the study conditions;
A test positive for the HIV-1 or HIV-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 admission;
Pregnant, breast-feeding or of childbearing potential;
Other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol.
At randomisation (completion of the baseline period):
Treated with levodopa/DDCI in a 10:1 ratio or in a controlled-release formulation during the baseline period;
Treated with apomorphine during the baseline period;
A clinically relevant ECG abnormality.

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

Ukraine4 sites

Ukrainian State Scientific Research Institute of Medical and Social Problems of Disability, Department of Neurology and Adjustment Conditions
Dnipropetrovsk, 49027
Department No. 23 of Communal setting of medical care Kharkiv's regional clinical psychiatric hospital No. 3,
Kharkiv, 61068
Department of Neuroinfections and multiple sclerosis, SI "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine
Kharkiv, 61068
Department of Clinical Physiology and Pathology of Extrapyramidal Nervous System SI "Institute of Gerontology, AMS Ukraine"
Kyiv, 04114

Other trials in Ukraine

Romania3 sites

Department of Neurology C.M.D.T.A. NEOMED
Brasov, 500 283
Department of Neurology-Quantum Medical Center
Bucharest, 024 092
Clinica de Medicina Fizica si Recuperare Medicala-Spitalul Clinic Judetean de Urgenta Craiova
Craiova, 200 642

Other trials in Romania

About this study

Official title: Multicentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations ("Wearing-off" Phenomenon)

Read the detailed description

Multicentre, double-blind, randomised, placebo-controlled study in four parallel groups of PD patients treated with standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and with motor fluctuations ("wearing-off" phenomenon)

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

PlaceboDrug
Also called PLC
once-daily
BIA 9-1067Drug
Also called OPC, Opicapone
BIA 9-1067 - 5 mg single-dose
BIA 9-1067Drug
Also called OPC, Opicapone
BIA 9-1067 - 15 mg single-dose
BIA 9-1067Drug
Also called OPC, Opicapone
BIA 9-1067 - 30 mg 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 NCT01568047
Study group	Role	What they receive
Placebo	Placebo comparator	PLC, Placebo Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half Receives: Drug: Placebo; Drug: Levodopa/Carbidopa; Drug: Levodopa/Benzerazide
BIA 9-1067 - 5 mg	Experimental	5 mg BIA 9-1067 (OPC, Opicapone) Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half Receives: Drug: BIA 9-1067; Drug: Levodopa/Carbidopa; Drug: Levodopa/Benzerazide
BIA 9-1067 - 15 mg	Experimental	15 mg BIA 9-1067 (OPC, Opicapone) Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half Receives: Drug: BIA 9-1067; Drug: Levodopa/Carbidopa; Drug: Levodopa/Benzerazide
BIA 9-1067 - 30 mg	Experimental	30 mg BIA 9-1067 (OPC, Opicapone) Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half Receives: Drug: BIA 9-1067; Drug: Levodopa/Carbidopa; Drug: Levodopa/Benzerazide

What is being measured

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

Cmax - Observed Maximum Concentration
Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.
Test Period - After the baseline period during the 21 to 28 days
Measured: 28 days
Tmax - Time to Observed Maximum Concentration
Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.
Test Period - After the baseline period during the 21 to 28 days
Measured: 28 days

Secondary outcomes (1)

AUC0-6 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])
Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.
Test Period - After the baseline period during the 21 to 28 days
Measured: 28 days

Timeline

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

Feb 2010Jun 2010

First posted2 Apr 2012 (estimated)
Study startFeb 2010
Primary completionJun 2010
Study completionJun 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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01568047
Sponsor's protocol ID: BIA-91067-202
Other IDs: 2009-012897-12, 2009
Status last verified: Nov 2015
First submitted: 29 Mar 2012
Last updated: 24 Dec 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 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations ("Wearing-off" Phenomenon)
ClinicalTrials.gov ID: NCT01568047
Acronym / sponsor ID: BIA-91067-202
Conditions: Parkinson's Disease
Keywords: Parkinson Disease, BIA 9-1067
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 2 Apr 2012 (estimated)
Results: Posted 8 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: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo, Drug: Levodopa/Carbidopa, Drug: Levodopa/BenzerazidePLC, Placebo Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
BIA 9-1067 - 5 mg	Experimental	Drug: BIA 9-1067, Drug: Levodopa/Carbidopa, Drug: Levodopa/Benzerazide5 mg BIA 9-1067 (OPC, Opicapone) Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
BIA 9-1067 - 15 mg	Experimental	Drug: BIA 9-1067, Drug: Levodopa/Carbidopa, Drug: Levodopa/Benzerazide15 mg BIA 9-1067 (OPC, Opicapone) Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
BIA 9-1067 - 30 mg	Experimental	Drug: BIA 9-1067, Drug: Levodopa/Carbidopa, Drug: Levodopa/Benzerazide30 mg BIA 9-1067 (OPC, Opicapone) Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Who may qualify

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

Key inclusion criteria (12 listed)

Male or female of non-childbearing potential (by reason of surgery or postmenopausal);
Age ≥ 30 years;
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;
Modified Hoehn and Yahr stage of less than 5 in the "off" state; mean duration of "off" state ≥ 1.5 h during waking hours (based on historical information);

Key exclusion criteria (19 listed)

Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome);
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 2 weeks prior to admission;
Treated with any investigational product within 1 month prior to admission (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;
Known hypersensitivity to any of the ingredients of the investigational products;

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
PlaceboAlso: PLConce-daily	Drug	Placebo
BIA 9-1067Also: OPC, OpicaponeBIA 9-1067 - 5 mg single-dose	Drug	BIA 9-1067 - 5 mg
BIA 9-1067Also: OPC, OpicaponeBIA 9-1067 - 15 mg single-dose	Drug	BIA 9-1067 - 15 mg
BIA 9-1067Also: OPC, OpicaponeBIA 9-1067 - 30 mg single-dose	Drug	BIA 9-1067 - 30 mg
Levodopa/CarbidopaAlso: SinemetLevodopa 100 mg Carbidopa 25 mg	Drug	BIA 9-1067 - 15 mg, BIA 9-1067 - 30 mg, BIA 9-1067 - 5 mg, Placebo
Levodopa/BenzerazideAlso: Madopar®/Restex®Levodopa 100 mg Benzerazide 25 mg	Drug	BIA 9-1067 - 15 mg, BIA 9-1067 - 30 mg, BIA 9-1067 - 5 mg, Placebo

Primary outcome

Cmax - Observed Maximum Concentration
Time frame: 28 days
Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses. Test Period - After the baseline period during the 21 to 28 days
Tmax - Time to Observed Maximum Concentration
Time frame: 28 days
Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses. Test Period - After the baseline period during the 21 to 28 days

1 secondary outcome

AUC0-6 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])
Time frame: 28 days

Results and safety

Results posted to the registry on 8 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
Placebo	10	9
BIA 9-1067 (5 mg)	10	9
BIA 9-1067 (15 mg)	10	9
BIA 9-1067 (30 mg)	10	9

Primary outcome: Cmax - Observed Maximum Concentration

Time frame: 28 days. Mean (Standard Deviation). Unit: ng/mL

Measure	Placebo n = 9	BIA 9-1067 5 mg n = 9	BIA 9-1067 15 mg n = 9	BIA 9-1067 30 mg n = 9
Cmax (levodopa) Baseline	1484 (26.0)	1446 (37.6)	1753 (43.4)	1832 (49.1)
Cmax (levodopa) Test	1203 (29.4)	1868 (31.8)	1806 (28.4)	2584 (33.7)
Cmax (3-OMD) Baseline	4701 (46.7)	4631 (31.6)	3529 (50.7)	6222 (63.6)
Cmax (3-OMD) Test	3770 (45.0)	2633 (21.2)	1197 (71.8)	1603 (36.2)
Cmax (BIA 9-067) Test	NA (NA)	240 (186)	233 (71.8)	480 (64.4)

Primary outcome: Tmax - Time to Observed Maximum Concentration

Time frame: 28 days. Median (Full Range). Unit: ng/mL

Measure	Placebo n = 9	BIA 9-1067 5 mg n = 9	BIA 9-1067 15 mg n = 9	BIA 9-1067 30 mg n = 9
Cmax (levodopa) Baseline	1.0 (0.5 to 4.0)	1.0 (0.5 to 4.0)	0.5 (0.5 to 1.0)	1.0 (0.5 to 2.0)
Cmax (levodopa) Test	1.0 (0.5 to 2.0)	1.0 (0.5 to 2.0)	0.75 (0.5 to 2.0)	0.5 (0.5 to 3.0)
Cmax (3-OMD) Baseline	2.0 (0.0 to 4.0)	3.0 (1.0 to 6.0)	2.25 (0.0 to 3.0)	3.0 (0.0 to 6.0)
Cmax (3-OMD) Test	2.0 (0.0 to 6.0)	1.5 (0.0 to 3.0)	3.0 (2.0 to 4.0)	3.0 (1.0 to 4.0)
Cmax (BIA 9-067) Test	NA (NA to NA)	2.0 (1.0 to 4.0)	2.0 (1.0 to 4.0)	2.0 (1.0 to 4.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 16 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 10 (0%)	5 of 10 (50%)	Not reported
BIA 9-1067 (5 mg)	0 of 10 (0%)	1 of 10 (10%)	Not reported
BIA 9-1067 (15 mg)	0 of 10 (0%)	1 of 10 (10%)	Not reported
BIA 9-1067 (30 mg)	0 of 10 (0%)	4 of 10 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 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.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 2 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 7 sites in 2 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 12 inclusion and 19 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 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Ukraine, Romania. 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. Some participants in this study may receive a placebo. 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 8 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 - Observed Maximum Concentration (time frame: 28 days). 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 NCT01568047.

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 24 Dec 2015.