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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Safinamide Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Safinamide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Dose (50mg/day) Drug: Safinamide
Experimental: High Dose (100mg/day) Drug: Safinamide
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286935


Sponsors and Collaborators
Newron Pharmaceuticals SPA
Investigators
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Principal Investigator: See Study 016 for details PI's are the same as for study NW-1015/016/III/2006
More Information
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Additional Information:

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Responsible Party: Dr Ravi Anand (Chief Medical Officer), Newron Pharmaceuticals S.p.A.
ClinicalTrials.gov Identifier: NCT01286935    
Other Study ID Numbers: NW-1015/018/III/2006
2006-005861-21 ( EudraCT Number )
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: January 31, 2011
Last Verified: January 2011
Keywords provided by Newron Pharmaceuticals SPA:
Parkinson's Disease
PD
Levodopa
Patients with idiopathic Parkinson's Disease with motor fluctuations,
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases