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18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Safinamide
Safinamide
Placebo
Sponsored by
Newron Pharmaceuticals SPA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, PD, Levodopa, Patients with idiopathic Parkinson's Disease with motor fluctuations,

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient completed 24 weeks of treatment in Study 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24, as part of the Retrieved Dropout (RDO) population.
  • The patient was compliant with taking study medication in Study 016.
  • The patient is willing to participate in the study and signed an approved Informed Consent form.

Exclusion Criteria:

  • The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
  • The patient has shown clinically significant deterioration during participation in Study 016, and has reached Hoehn and Yahr Stage V.
  • The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Low Dose (50mg/day)

    High Dose (100mg/day)

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean change in the dyskinesias rating scale (DRS) during "on" time
    mean change in the dyskinesias rating scale (DRS) during "on" time from baseline (study 016) to endpoint (last visit in study 018).

    Secondary Outcome Measures

    Endpoints include 'ON time', responder rates and UPDRS IV change
    Chge in ON time (ON+ON minor dysk), Diary Resp Rate at 12-m, 18 & 24 m on the ITT&mITT pop&pts who completed 2-yr period UPDRS IV chge in total score,items 32-35 & 32-34 Time develop tblsome dysk(> 30min incr of tblsome dysk) Time develop any (minor &/or tblsome) dysk (> 30 min incr of dysk) Chge ADLs during ON, vs pbo(UPDRS II) Maintenance of effect in UPDRS II "resp'(resp >=20% impr in ADLs). chge in L-dopa dose chge in any PD(other than L-dopa)drug dose Chge in UPDRS III, CGI-C and CGI-S Chge in diary categories(ON, OFF, ON minor dysk, ON tblsome dysk, ASLEEP)

    Full Information

    First Posted
    August 23, 2010
    Last Updated
    January 28, 2011
    Sponsor
    Newron Pharmaceuticals SPA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01286935
    Brief Title
    18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD
    Official Title
    A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    August 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Newron Pharmaceuticals SPA

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease
    Keywords
    Parkinson's Disease, PD, Levodopa, Patients with idiopathic Parkinson's Disease with motor fluctuations,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    544 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low Dose (50mg/day)
    Arm Type
    Experimental
    Arm Title
    High Dose (100mg/day)
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Safinamide
    Intervention Type
    Drug
    Intervention Name(s)
    Safinamide
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Mean change in the dyskinesias rating scale (DRS) during "on" time
    Description
    mean change in the dyskinesias rating scale (DRS) during "on" time from baseline (study 016) to endpoint (last visit in study 018).
    Time Frame
    Up to 104 weeks (from baseline 016 to EOS study 018)
    Secondary Outcome Measure Information:
    Title
    Endpoints include 'ON time', responder rates and UPDRS IV change
    Description
    Chge in ON time (ON+ON minor dysk), Diary Resp Rate at 12-m, 18 & 24 m on the ITT&mITT pop&pts who completed 2-yr period UPDRS IV chge in total score,items 32-35 & 32-34 Time develop tblsome dysk(> 30min incr of tblsome dysk) Time develop any (minor &/or tblsome) dysk (> 30 min incr of dysk) Chge ADLs during ON, vs pbo(UPDRS II) Maintenance of effect in UPDRS II "resp'(resp >=20% impr in ADLs). chge in L-dopa dose chge in any PD(other than L-dopa)drug dose Chge in UPDRS III, CGI-C and CGI-S Chge in diary categories(ON, OFF, ON minor dysk, ON tblsome dysk, ASLEEP)
    Time Frame
    Up to 104 weeks (from baseline 016 to EOS study 018)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient completed 24 weeks of treatment in Study 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24, as part of the Retrieved Dropout (RDO) population. The patient was compliant with taking study medication in Study 016. The patient is willing to participate in the study and signed an approved Informed Consent form. Exclusion Criteria: The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study. The patient has shown clinically significant deterioration during participation in Study 016, and has reached Hoehn and Yahr Stage V. The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    See Study 016 for details
    Organizational Affiliation
    PI's are the same as for study NW-1015/016/III/2006
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.newron.com/
    Description
    Related Info

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    18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD

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