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出境医 / 临床实验 / Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease

Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease

Study Description
Brief Summary:
The purpose of this study is to describe the safety and efficacy of opicapone plus standard of care in elderly patients with PD in the real-world setting

Condition or disease Intervention/treatment
Parkinson Disease Drug: Opicapone Drug: Levodopa (L-DOPA) + Standard care

Detailed Description:

This will be a multinational, multicentre, prospective non-interventional study in elderly patients with PD. Approximately 100 patients with PD will be recruited by specialists from approximately 37 sites in European countries. The total enrolment period will be one year, and each patient will be followed for up to one year after enrolment.

PD patients with end-of-dose motor fluctuations suitable for additional treatment optimization will be included in the study and split into 2 cohorts:

  • Cohort 1: 50 patients; standard of care (including L-DOPA) + starting opicapone
  • Cohort 2: 50 patients; standard of care (including L-DOPA Data will be collected at baseline (date of enrolment), 1 month, 3 months, 6 months, 9 months, and 12 months after enrolment.

This non-interventional study does not recommend the use of any specific treatments. Use of opicapone and of standard of care are only driven by the physician's decision.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Cohort 1
Standard of care (including L-DOPA) + starting opicapone
Drug: Opicapone
Capsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision.
Other Name: Ongentys

Drug: Levodopa (L-DOPA) + Standard care
Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision.

Cohort 2
Standard of care (including L-DOPA)
Drug: Levodopa (L-DOPA) + Standard care
Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision.

Outcome Measures
Primary Outcome Measures :
  1. Percentage of patients having at least one Adverse Event (AE) [ Time Frame: through study completion, an average of 1 year ]
    All AEs reporting


Secondary Outcome Measures :
  1. Clinical Global Impression of Improvement (CGI-I) [ Time Frame: at Follow-up visit at 1, 3, 6, 9, 12 months ]
    hange of score from baseline at each follow-up visit (from 0=good health to 100=poor health).

  2. Parkinson Disease Questionnaire (PDQ-8) [ Time Frame: at baseline, Follow-up visit at 6,12 months ]
    hange of score from baseline at each follow-up visit (from 0=good health to 100=poor health).

  3. Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: at baseline, Follow-up visit at 6,12 months ]
    change from baseline at each follow-up visit for each of the 4 sections and for the total score (from 0=no disability to 199=total disability).

  4. Montreal Cognitive Assessment (MoCA) [ Time Frame: at baseline, Follow-up visit at 6,12 months ]
    change from baseline at each follow-up visit (30-point test; score >26 is normal).

  5. Patients' Global Impressions of Change (PGI-C) [ Time Frame: at Follow-up visit at 1, 3, 6, 9, 12 months ]
    Percentage of patients for each item at each follow-up visit (from 1=very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment).


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study plans to recruit approximately 100 elderly PD patients from neurology clinics
Criteria

Inclusion Criteria:

  • Patient or legally acceptable representative willing and able to provide informed consent as mandated by local regulation
  • Patient with clinical diagnosis of idiopathic PD (excluding non-idiopathic PD: atypical Parkinsonism, secondary [acquired or symptomatic] Parkinsonism, Parkinson-plus syndrome)
  • Patient with age >=75 years at enrolment
  • Patient with end-of-dose motor fluctuations suitable for additional treatment optimization

Exclusion Criteria:

  • Patient concurrently participating in any clinical trial
  • Patient who used tolcapone or opicapone previously
  • For the patient who starts opicapone: concomitant treatment with entacapone or tolcapone is not allowed
  • Patient with any contraindications to Ongentys use
  • Patient with any concomitant medical condition that could interfere with study assessments
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Diogo Magalhães, MD +351 22 986 6100 diogo.magalhaes@bial.com
Contact: Francisco Rocha, BSc +351 22 986 6100 francisco.rocha@bial.com

Locations
Layout table for location information
United Kingdom
Norfolk&Norwich University Hospitals Recruiting
Norwich, Norfolk, United Kingdom, NR47UY
Contact: Rocha Francisco, BSc       francisco.rocha@bial.com   
Sponsors and Collaborators
Bial - Portela C S.A.
Tracking Information
First Submitted Date April 23, 2019
First Posted Date May 22, 2019
Last Update Posted Date December 31, 2020
Actual Study Start Date April 28, 2020
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2019)
Percentage of patients having at least one Adverse Event (AE) [ Time Frame: through study completion, an average of 1 year ]
All AEs reporting
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 21, 2019)
  • Clinical Global Impression of Improvement (CGI-I) [ Time Frame: at Follow-up visit at 1, 3, 6, 9, 12 months ]
    hange of score from baseline at each follow-up visit (from 0=good health to 100=poor health).
  • Parkinson Disease Questionnaire (PDQ-8) [ Time Frame: at baseline, Follow-up visit at 6,12 months ]
    hange of score from baseline at each follow-up visit (from 0=good health to 100=poor health).
  • Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: at baseline, Follow-up visit at 6,12 months ]
    change from baseline at each follow-up visit for each of the 4 sections and for the total score (from 0=no disability to 199=total disability).
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: at baseline, Follow-up visit at 6,12 months ]
    change from baseline at each follow-up visit (30-point test; score >26 is normal).
  • Patients' Global Impressions of Change (PGI-C) [ Time Frame: at Follow-up visit at 1, 3, 6, 9, 12 months ]
    Percentage of patients for each item at each follow-up visit (from 1=very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
Official Title A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
Brief Summary The purpose of this study is to describe the safety and efficacy of opicapone plus standard of care in elderly patients with PD in the real-world setting
Detailed Description

This will be a multinational, multicentre, prospective non-interventional study in elderly patients with PD. Approximately 100 patients with PD will be recruited by specialists from approximately 37 sites in European countries. The total enrolment period will be one year, and each patient will be followed for up to one year after enrolment.

PD patients with end-of-dose motor fluctuations suitable for additional treatment optimization will be included in the study and split into 2 cohorts:

  • Cohort 1: 50 patients; standard of care (including L-DOPA) + starting opicapone
  • Cohort 2: 50 patients; standard of care (including L-DOPA Data will be collected at baseline (date of enrolment), 1 month, 3 months, 6 months, 9 months, and 12 months after enrolment.

This non-interventional study does not recommend the use of any specific treatments. Use of opicapone and of standard of care are only driven by the physician's decision.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study plans to recruit approximately 100 elderly PD patients from neurology clinics
Condition Parkinson Disease
Intervention
  • Drug: Opicapone
    Capsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision.
    Other Name: Ongentys
  • Drug: Levodopa (L-DOPA) + Standard care
    Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision.
Study Groups/Cohorts
  • Cohort 1
    Standard of care (including L-DOPA) + starting opicapone
    Interventions:
    • Drug: Opicapone
    • Drug: Levodopa (L-DOPA) + Standard care
  • Cohort 2
    Standard of care (including L-DOPA)
    Intervention: Drug: Levodopa (L-DOPA) + Standard care
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 Recruiting
Estimated Enrollment
 (submitted: May 21, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient or legally acceptable representative willing and able to provide informed consent as mandated by local regulation
  • Patient with clinical diagnosis of idiopathic PD (excluding non-idiopathic PD: atypical Parkinsonism, secondary [acquired or symptomatic] Parkinsonism, Parkinson-plus syndrome)
  • Patient with age >=75 years at enrolment
  • Patient with end-of-dose motor fluctuations suitable for additional treatment optimization

Exclusion Criteria:

  • Patient concurrently participating in any clinical trial
  • Patient who used tolcapone or opicapone previously
  • For the patient who starts opicapone: concomitant treatment with entacapone or tolcapone is not allowed
  • Patient with any contraindications to Ongentys use
  • Patient with any concomitant medical condition that could interfere with study assessments
Sex/Gender
Sexes Eligible for Study: All
Ages 75 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Diogo Magalhães, MD +351 22 986 6100 diogo.magalhaes@bial.com
Contact: Francisco Rocha, BSc +351 22 986 6100 francisco.rocha@bial.com
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03959540
Other Study ID Numbers BIA-91067-402
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Bial - Portela C S.A.
Study Sponsor Bial - Portela C S.A.
Collaborators Not Provided
Investigators Not Provided
PRS Account Bial - Portela C S.A.
Verification Date December 2020

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