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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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ClinicalTrials.gov Identifier: NCT01286935
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : January 31, 2011
Sponsor:
Information provided by:

August 23, 2010
January 31, 2011
January 31, 2011
August 2007
April 2010   (Final data collection date for primary outcome measure)
Mean change in the dyskinesias rating scale (DRS) during "on" time [ Time Frame: Up to 104 weeks (from baseline 016 to EOS study 018) ]
mean change in the dyskinesias rating scale (DRS) during "on" time from baseline (study 016) to endpoint (last visit in study 018).
Same as current
No Changes Posted
Endpoints include 'ON time', responder rates and UPDRS IV change [ Time Frame: Up to 104 weeks (from baseline 016 to EOS study 018) ]
  • 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)
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: Safinamide
  • Drug: Placebo
  • Experimental: Low Dose (50mg/day)
    Intervention: Drug: Safinamide
  • Experimental: High Dose (100mg/day)
    Intervention: Drug: Safinamide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
544
August 2010
April 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01286935
NW-1015/018/III/2006
2006-005861-21 ( EudraCT Number )
Yes
Not Provided
Not Provided
Dr Ravi Anand (Chief Medical Officer), Newron Pharmaceuticals S.p.A.
Newron
Not Provided
Principal Investigator: See Study 016 for details PI's are the same as for study NW-1015/016/III/2006
Newron
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP