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
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
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
NCT ID
NCT01286935
First Posted
August 23, 2010
Last Updated
January 28, 2011
Sponsor
Newron Pharmaceuticals SPA
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
Learn more about this trial
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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