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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:
Newron Pharmaceuticals SPA

Tracking Information
First Submitted Date  ICMJE August 23, 2010
First Posted Date  ICMJE January 31, 2011
Last Update Posted Date January 31, 2011
Study Start Date  ICMJE August 2007
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2011)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2011)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: Safinamide
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Low Dose (50mg/day)
    Intervention: Drug: Safinamide
  • Experimental: High Dose (100mg/day)
    Intervention: Drug: Safinamide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2011)
544
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01286935
Other Study ID Numbers  ICMJE NW-1015/018/III/2006
2006-005861-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Ravi Anand (Chief Medical Officer), Newron Pharmaceuticals S.p.A.
Study Sponsor  ICMJE Newron Pharmaceuticals SPA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: See Study 016 for details PI's are the same as for study NW-1015/016/III/2006
PRS Account Newron Pharmaceuticals SPA
Verification Date January 2011

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