NCT01568047

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

7 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

February 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.8 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 8, 2015

Completed
Last Updated

December 24, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

March 29, 2012

Results QC Date

February 5, 2014

Last Update Submit

November 23, 2015

Conditions

Parkinson's Disease

Keywords

Parkinson DiseaseBIA 9-1067

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    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])

    28 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

PLC, Placebo Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Drug: PlaceboDrug: Levodopa/CarbidopaDrug: 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

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

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

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

Interventions

PlaceboDRUG

once-daily

Also known as: PLC
Placebo
BIA 9-1067DRUG

BIA 9-1067 - 5 mg single-dose

Also known as: OPC, Opicapone
BIA 9-1067 - 5 mg
Levodopa/CarbidopaDRUG

Levodopa 100 mg Carbidopa 25 mg

Also known as: Sinemet
BIA 9-1067 - 15 mgBIA 9-1067 - 30 mgBIA 9-1067 - 5 mgPlacebo
Levodopa/BenzerazideDRUG

Levodopa 100 mg Benzerazide 25 mg

Also known as: Madopar®/Restex®
BIA 9-1067 - 15 mgBIA 9-1067 - 30 mgBIA 9-1067 - 5 mgPlacebo

Eligibility Criteria

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

You may qualify if:

  • 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);
  • 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.

You may not qualify if:

  • 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;
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Department of Neurology C.M.D.T.A. NEOMED

Brasov, 500 283, Romania

Location

Department of Neurology-Quantum Medical Center

Bucharest, 024 092, Romania

Location

Clinica de Medicina Fizica si Recuperare Medicala-Spitalul Clinic Judetean de Urgenta Craiova

Craiova, 200 642, Romania

Location

Ukrainian State Scientific Research Institute of Medical and Social Problems of Disability, Department of Neurology and Adjustment Conditions

Dnipropetrovsk, 49027, Ukraine

Location

Department No. 23 of Communal setting of medical care Kharkiv's regional clinical psychiatric hospital No. 3,

Kharkiv, 61068, Ukraine

Location

Department of Neuroinfections and multiple sclerosis, SI "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine

Kharkiv, 61068, Ukraine

Location

Department of Clinical Physiology and Pathology of Extrapyramidal Nervous System SI "Institute of Gerontology, AMS Ukraine"

Kyiv, 04114, 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

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 2, 2012

Study Start

February 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

December 24, 2015

Results First Posted

January 8, 2015

Record last verified: 2015-11

Locations

RO(3)UA(4)