18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD
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
2 other identifiers
interventional
544
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2007
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 23, 2010
CompletedFirst Posted
Study publicly available on registry
January 31, 2011
CompletedJanuary 31, 2011
January 1, 2011
2.7 years
August 23, 2010
January 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Up to 104 weeks (from baseline 016 to EOS study 018)
Secondary Outcomes (1)
Endpoints include 'ON time', responder rates and UPDRS IV change
Up to 104 weeks (from baseline 016 to EOS study 018)
Study Arms (3)
Low Dose (50mg/day)
EXPERIMENTALHigh Dose (100mg/day)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
See Study 016 for details
PI's are the same as for study NW-1015/016/III/2006
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 23, 2010
First Posted
January 31, 2011
Study Start
August 1, 2007
Primary Completion
April 1, 2010
Study Completion
August 1, 2010
Last Updated
January 31, 2011
Record last verified: 2011-01