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

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ClinicalTrials.gov Identifier: NCT03959540
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

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.


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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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

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.




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).



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959540


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

Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT03959540     History of Changes
Other Study ID Numbers: BIA-91067-402
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Opicapone
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors