NCT01568034

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2

Geographic Reach
3 countries

3 active sites

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

Study Start

First participant enrolled

April 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 12, 2015

Completed
Last Updated

January 12, 2015

Status Verified

December 1, 2014

Enrollment Period

10 months

First QC Date

March 29, 2012

Results QC Date

February 5, 2014

Last Update Submit

December 19, 2014

Conditions

Parkinson's Disease

Keywords

Parkinson's DiseaseBIA 9-1067

Outcome Measures

Primary Outcomes (2)

  • Cmax - Maximum Plasma Concentration Day 3

    Cmax - Maximum plasma concentration (ng/mL)

    Day 3

  • Tmax = Time to Cmax Day 3

    tmax = time to Cmax (values are median)

    Day 3

Secondary Outcomes (1)

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

    Day 3

Study Arms (4)

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

Drug: BIA 9-1067Drug: PlaceboDrug: Levodopa/CarbidopaDrug: 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

Drug: BIA 9-1067Drug: PlaceboDrug: Levodopa/CarbidopaDrug: 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

Drug: BIA 9-1067Drug: PlaceboDrug: Levodopa/CarbidopaDrug: 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

Drug: BIA 9-1067Drug: PlaceboDrug: Levodopa/CarbidopaDrug: Levodopa/Benzerazide

Interventions

BIA 9-1067DRUG

BIA 9-1067 - 25 mg single-dose

Also known as: OPC, Opicapone
Treatment Sequence ATreatment Sequence BTreatment Sequence CTreatment Sequence D
PlaceboDRUG

single-dose

Also known as: PLC
Treatment Sequence ATreatment Sequence BTreatment Sequence CTreatment Sequence D
Levodopa/CarbidopaDRUG

Levodopa 100 mg Carbidopa 25 mg

Also known as: Sinemet
Treatment Sequence ATreatment Sequence BTreatment Sequence CTreatment Sequence D
Levodopa/BenzerazideDRUG

Levodopa 100 mg Benzerazide 25 mg

Also known as: Madopar®/Restex®
Treatment Sequence ATreatment Sequence BTreatment Sequence CTreatment Sequence D

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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;
  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Lisbon, 1649-035, Portugal

Location

Spitalul Clinic Colentina - Clinica de Neurologie

Bucharest, 020125, Romania

Location

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

Kyiv, 04050, Ukraine

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicaponecarbidopa, levodopa drug combinationLevodopa

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 ProteinsTyrosine

Results Point of Contact

Title
Head of Clinical Research
Organization
BIAL - Portela & Cª S.A.
clinical.trials@bial.com
+351-229866100

Study Officials

  • Joaquim Ferreira, MD, PhD

    Hospital de Santa Maria, Lisbon

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 2, 2012

Study Start

April 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

January 12, 2015

Results First Posted

January 12, 2015

Record last verified: 2014-12

Locations

RO(1)UA(1)PT(1)