NCT01227655

Brief 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. Promising results have been obtained for BIA 9-1067 in previous studies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
427

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 13, 2015

Completed
Last Updated

October 19, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

October 22, 2010

Results QC Date

November 26, 2014

Last Update Submit

September 21, 2015

Conditions

Parkinson's Disease

Keywords

ParkinsonPDWearing-offLevodopa/DDCI

Outcome Measures

Primary Outcomes (1)

  • 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.

    14-15 weeks

Secondary Outcomes (3)

  • UPDRS (Unified Parkinson's Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON)

    14-15 weeks

  • Parkinson's Disease Sleep Scale (PDSS)

    14-15 weeks

  • Non-motor Symptoms Scale (NMSS)

    14-15 weeks

Study Arms (3)

BIA 9-1067 25 mg once daily (QD).

EXPERIMENTAL

BIA 9-1067, OPC, Opicapone 25 mg once daily (QD).

Drug: BIA 9-1067Drug: LevodopaDrug: CarbidopaDrug: Benserazide

BIA 9-1067 50 mg once daily (QD).

EXPERIMENTAL

BIA 9-1067, OPC, Opicapone 50 mg once daily (QD).

Drug: BIA 9-1067Drug: LevodopaDrug: CarbidopaDrug: Benserazide

Placebo

PLACEBO COMPARATOR

PLC, Placebo

Drug: PlaceboDrug: LevodopaDrug: CarbidopaDrug: Benserazide

Interventions

BIA 9-1067DRUG

Capsules will be used.

Also known as: Opicapone
BIA 9-1067 25 mg once daily (QD).BIA 9-1067 50 mg once daily (QD).
PlaceboDRUG

comparator

Also known as: placebo; PLC
Placebo
LevodopaDRUG
Also known as: L-Dopa
BIA 9-1067 25 mg once daily (QD).BIA 9-1067 50 mg once daily (QD).Placebo
CarbidopaDRUG

DOPA decarboxylase inhibitor (DDCI)

BIA 9-1067 25 mg once daily (QD).BIA 9-1067 50 mg once daily (QD).Placebo
BenserazideDRUG

DOPA decarboxylase inhibitor

BIA 9-1067 25 mg once daily (QD).BIA 9-1067 50 mg once daily (QD).Placebo

Eligibility Criteria

Age30 Years - 83 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bial - Portela & Cª, S.A.

S. Mamede Do Coronado, 4745-457, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 28027332DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicaponeLevodopaCarbidopaBenserazide

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosineMethyldopaHydrazines

Results Point of Contact

Title
Head of Clinical Research
Organization
Bial - Portela & Cª, S.A.
jose.rocha@bial.com
+351 229 866 100

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 25, 2010

Study Start

March 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 19, 2015

Results First Posted

January 13, 2015

Record last verified: 2015-09

Locations

PT(1)