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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

This study has been completed.
Information provided by:
Newron Identifier:
First received: August 23, 2010
Last updated: January 28, 2011
Last verified: January 2011
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 Intervention Phase
Parkinson's Disease
Drug: Safinamide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Newron:

Primary Outcome Measures:
  • 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:
  • 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)

Enrollment: 544
Study Start Date: August 2007
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose (50mg/day) Drug: Safinamide
Experimental: High Dose (100mg/day) Drug: Safinamide
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT01286935

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

Additional Information:
Responsible Party: Dr Ravi Anand (Chief Medical Officer), Newron Pharmaceuticals S.p.A. Identifier: NCT01286935     History of Changes
Other Study ID Numbers: NW-1015/018/III/2006
2006-005861-21 ( EudraCT Number )
Study First Received: August 23, 2010
Last Updated: January 28, 2011

Keywords provided by Newron:
Parkinson's Disease
Patients with idiopathic Parkinson's Disease with motor fluctuations,

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 25, 2017