Parkinson's DiseasePhase 3BIPARKIINCT01227655

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.

A Phase 3 study testing BIA 9-1067, Levodopa and Carbidopa in people with Parkinson's Disease, run by Bial - Portela C S.A. at 1 site in Portugal.

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

Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year. BIA 9-1067 is currently being developed by BIAL (Portela \& Cª,S.A.) to be used in addition to L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Read more about this study

Who is it for?: Ages 30 to 83 years
Conditions the study is for: Parkinson's Disease
What is being tested?: BIA 9-1067, Levodopa and Carbidopa
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 427 participants
Where: 1 sitePortugal
Study dates: Mar 2011to Jul 2012
Phase: Phase 3
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 83 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to comprehend and willing to sign an informed consent form.
Male and female subjects between 30 and 83 years old, inclusive.
Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for at least 3 years.
Disease severity Stages I-III (modified Hoehn \&Yahr staging) at ON.
Treated with L-DOPA/DDCI for at least 1 year with clear clinical improvement.
Treated with 3 to 8 daily doses of L-DOPA/DDCI, which can include a slow-release formulation.
On a stable regimen of L-DOPA/DDCI and other anti-PD drugs for at least 4 weeks before screening.
Signs of "wearing-off" phenomenon (end-of-dose deterioration) for a minimum of 4 weeks before screening with average total daily OFF time while awake of at least 1.5 hours, excluding the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on the investigator's judgment.

Who cannot join

Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
Dyskinesia disability score >3 in the Unified Parkinson's Disease Rating Scale UPDRS) Sub-section IV A, item 33.
Severe and/or unpredictable OFF periods.
Treatment with prohibited medication: entacapone, tolcapone, neuroleptics, venlafaxine, MAO inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1mg/day), or antiemetics with antidopaminergic action (except domperidone) within the month before screening.
Treatment with apomorphine within the month before screening or likely to be needed at any time during the study.
Dosage change of concomitant anti-PD medication within 4 weeks of screening.

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Previous or planned (during the entire study duration, including the OL period)deep brain stimulation.
Previous stereotactic surgery (e.g. pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period.
Any investigational medicinal product within the 3 months (or within 5 half-lives, whichever is longer) before screening.
Any medical condition that might place the subject at increased risk or interfere with assessments.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

Bial - Portela & Cª, S.A.
S. Mamede Do Coronado, 4745-457

Other trials in Portugal

About this study

Official title: Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study.

Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year.

BIA 9-1067 is currently being developed by BIAL (Portela \& Cª,S.A.) to be used in addition to L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising results have been obtained for BIA 9-1067 in previous studies.

Read the detailed description

This study aims to demonstrate the efficacy and safety of BIA 9-1067 used in addition to L-DOPA/DDCI to control the "wearing-off" phenomenon in patients with PD.

DDCI (DOPA decarboxylase inhibitors): benserazide and carbidopa

Conditions: Parkinson's Disease
Being tested: BIA 9-1067, Placebo, Levodopa, Carbidopa, Benserazide
Keywords: Parkinson, PD, Wearing-off, Levodopa/DDCI
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 Opicapone
Capsules will be used.
PlaceboDrug
Also called placebo; PLC
comparator
LevodopaDrug
Also called L-Dopa
CarbidopaDrug
DOPA decarboxylase inhibitor (DDCI)
BenserazideDrug
DOPA decarboxylase inhibitor

Study groups in NCT01227655
Study group	Role	What they receive
BIA 9-1067 25 mg once daily (QD).	Experimental	BIA 9-1067, OPC, Opicapone 25 mg once daily (QD). Receives: Drug: BIA 9-1067; Drug: Levodopa; Drug: Carbidopa; Drug: Benserazide
BIA 9-1067 50 mg once daily (QD).	Experimental	BIA 9-1067, OPC, Opicapone 50 mg once daily (QD). Receives: Drug: BIA 9-1067; Drug: Levodopa; Drug: Carbidopa; Drug: Benserazide
Placebo	Placebo comparator	PLC, Placebo Receives: Drug: Placebo; Drug: Levodopa; Drug: Carbidopa; Drug: Benserazide

What is being measured

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

Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor)
Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) compared with placebo, when administered with the existing treatment of L-DOPA plus a DDCI (DOPA decarboxylase inhibitor), in patients with PD and end-of-dose motor fluctuations. The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period.
Measured: 14-15 weeks

Secondary outcomes (3)

UPDRS (Unified Parkinson's Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON)
Total UPDRS SCORE (I, II (ON), and III) Change from Baseline to Endpoint
- UPDRS I evaluation of mentation, behavior, and mood
- UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food
- UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.
Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe
The final cumulative score will range from 0 (no disability) to 199 (total disability).
Measured: 14-15 weeks
Parkinson's Disease Sleep Scale (PDSS)
The Parkinson's disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.
Subscale has 0-10 ratings, where 0 = severe and 10 = normal
The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability.
Measured: 14-15 weeks
Non-motor Symptoms Scale (NMSS)
The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3
Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4
The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.
The NMSS total score is calculated by adding all domain scores (0-360), and lower scores mean less disability.
Measured: 14-15 weeks

Timeline

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

Mar 2011Jul 2012

First posted25 Oct 2010 (estimated)
Study startMar 2011
Primary completionJul 2012
Study completionJul 2012

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.
Publications (1)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 427 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01227655
Sponsor's protocol ID: BIA-91067-302
Other IDs: 2010-022366-27, BIA-91067-302
Acronym: BIPARKII
Status last verified: Sep 2015
First submitted: 22 Oct 2010
Last updated: 19 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lees 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

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?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study.
ClinicalTrials.gov ID: NCT01227655
Acronym / sponsor ID: BIPARKII / BIA-91067-302
Conditions: Parkinson's Disease
Keywords: Parkinson, PD, Wearing-off, Levodopa/DDCI
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 427 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 25 Oct 2010 (estimated)
Results: Posted 13 Jan 2015

Clinical summary

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

Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year.

Detailed description

This study aims to demonstrate the efficacy and safety of BIA 9-1067 used in addition to L-DOPA/DDCI to control the "wearing-off" phenomenon in patients with PD.

DDCI (DOPA decarboxylase inhibitors): benserazide and carbidopa

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
BIA 9-1067 25 mg once daily (QD).	Experimental	Drug: BIA 9-1067, Drug: Levodopa, Drug: Carbidopa, Drug: BenserazideBIA 9-1067, OPC, Opicapone 25 mg once daily (QD).
BIA 9-1067 50 mg once daily (QD).	Experimental	Drug: BIA 9-1067, Drug: Levodopa, Drug: Carbidopa, Drug: BenserazideBIA 9-1067, OPC, Opicapone 50 mg once daily (QD).
Placebo	Placebo comparator	Drug: Placebo, Drug: Levodopa, Drug: Carbidopa, Drug: BenserazidePLC, Placebo

Who may qualify

Ages: 30 to 83 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Able to comprehend and willing to sign an informed consent form.
Male and female subjects between 30 and 83 years old, inclusive.
Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for at least 3 years.
Disease severity Stages I-III (modified Hoehn \&Yahr staging) at ON.
Treated with L-DOPA/DDCI for at least 1 year with clear clinical improvement.

Key exclusion criteria (10 listed)

Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
Dyskinesia disability score >3 in the Unified Parkinson's Disease Rating Scale UPDRS) Sub-section IV A, item 33.
Severe and/or unpredictable OFF periods.
Treatment with prohibited medication: entacapone, tolcapone, neuroleptics, venlafaxine, MAO inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1mg/day), or antiemetics with antidopaminergic action (except domperidone) within the month before screening.
Treatment with apomorphine within the month before screening or likely to be needed at any time during the study.

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: OpicaponeCapsules will be used.	Drug	BIA 9-1067 25 mg once daily (QD)., BIA 9-1067 50 mg once daily (QD).
PlaceboAlso: placebo; PLCcomparator	Drug	Placebo
LevodopaAlso: L-Dopa	Drug	BIA 9-1067 25 mg once daily (QD)., BIA 9-1067 50 mg once daily (QD)., Placebo
CarbidopaDOPA decarboxylase inhibitor (DDCI)	Drug	BIA 9-1067 25 mg once daily (QD)., BIA 9-1067 50 mg once daily (QD)., Placebo
BenserazideDOPA decarboxylase inhibitor	Drug	BIA 9-1067 25 mg once daily (QD)., BIA 9-1067 50 mg once daily (QD)., Placebo

Primary outcome

Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor)
Time frame: 14-15 weeks
Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) compared with placebo, when administered with the existing treatment of L-DOPA plus a DDCI (DOPA decarboxylase inhibitor), in patients with PD and end-of-dose motor fluctuations. The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period.

3 secondary outcomes

UPDRS (Unified Parkinson's Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON)
Time frame: 14-15 weeks
Parkinson's Disease Sleep Scale (PDSS)
Time frame: 14-15 weeks
Non-motor Symptoms Scale (NMSS)
Time frame: 14-15 weeks

Results and safety

Results posted to the registry on 13 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
BIA 9-1067 25 mg	129	118
BIA 9-1067 50 mg	154	128
Placebo	144	130

Primary outcome: Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor)

Time frame: 14-15 weeks. Mean (Standard Deviation). Unit: minutes

Measure	BIA 9-1067 25 mg n = 125	BIA 9-1067 50 mg n = 147	Placebo n = 135
Value	-102.8 (159.42)	-124.0 (178.23)	-64.5 (155.35)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIA 9-1067 25 mg	4 of 125 (3.2%)	87 of 125 (69.6%)	Not reported
BIA 9-1067 50 mg	9 of 150 (6%)	108 of 150 (72%)	Not reported
Placebo	5 of 136 (3.7%)	68 of 136 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: 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.

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BIA 9-1067, Levodopa and Carbidopa in people with Parkinson's Disease, run by Bial - Portela C S.A. at 1 site in Portugal.

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 8 inclusion and 10 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 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 13 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?

Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor) (time frame: 14-15 weeks). 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 NCT01227655, which also lists 1 linked publication.

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 19 Oct 2015.