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

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ClinicalTrials.gov Identifier: NCT01568047
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : January 8, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Tracking Information
First Submitted Date  ICMJE March 29, 2012
First Posted Date  ICMJE April 2, 2012
Results First Submitted Date  ICMJE February 5, 2014
Results First Posted Date  ICMJE January 8, 2015
Last Update Posted Date December 24, 2015
Study Start Date  ICMJE February 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2014)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2012)
Change from baseline in absolute OFF-time at the end of the DB period [ Time Frame: 5 months ]
Efficay: "On/off" times will be recorded between admission to and discharge
Change History Complete list of historical versions of study NCT01568047 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2014)
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 ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2012)
  • Number of Adverse events/patient [ Time Frame: 5 months ]
    To investigate the tolerability and safety of repeated dosing of BIA 9-1067 (5 mg, 15 mg and 30 mg, once-daily), in comparison with placebo, in PD patients with motor fluctuations.
  • Unified Parkinson's Disease Rating Scale(UPDRS) [ Time Frame: 5 months ]
  • Modified Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 5 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients
Official Title  ICMJE 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)
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.
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: Placebo
    once-daily
    Other Name: PLC
  • Drug: BIA 9-1067
    BIA 9-1067 - 5 mg single-dose
    Other Name: OPC, Opicapone
  • Drug: BIA 9-1067
    BIA 9-1067 - 15 mg single-dose
    Other Name: OPC, Opicapone
  • Drug: BIA 9-1067
    BIA 9-1067 - 30 mg single-dose
    Other Name: OPC, Opicapone
  • Drug: Levodopa/Carbidopa
    Levodopa 100 mg Carbidopa 25 mg
    Other Name: Sinemet
  • Drug: Levodopa/Benzerazide
    Levodopa 100 mg Benzerazide 25 mg
    Other Name: Madopar®/Restex®
Study Arms  ICMJE
  • Placebo Comparator: Placebo

    PLC, Placebo

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

    Interventions:
    • Drug: Placebo
    • Drug: Levodopa/Carbidopa
    • Drug: Levodopa/Benzerazide
  • Experimental: BIA 9-1067 - 5 mg

    5 mg BIA 9-1067 (OPC, Opicapone)

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

    Interventions:
    • Drug: BIA 9-1067
    • Drug: Levodopa/Carbidopa
    • Drug: Levodopa/Benzerazide
  • Experimental: BIA 9-1067 - 15 mg

    15 mg BIA 9-1067 (OPC, Opicapone)

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

    Interventions:
    • Drug: BIA 9-1067
    • Drug: Levodopa/Carbidopa
    • Drug: Levodopa/Benzerazide
  • Experimental: BIA 9-1067 - 30 mg

    30 mg BIA 9-1067 (OPC, Opicapone)

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

    Interventions:
    • Drug: BIA 9-1067
    • Drug: Levodopa/Carbidopa
    • Drug: Levodopa/Benzerazide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2014)
40
Original Actual Enrollment  ICMJE
 (submitted: March 30, 2012)
46
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Romania,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01568047
Other Study ID Numbers  ICMJE BIA-91067-202
2009-012897-12 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bial - Portela C S.A.
Study Sponsor  ICMJE Bial - Portela C S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bial - Portela C S.A.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP