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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.
Sponsor:
Information provided by:
Newron Pharmaceuticals S.p.A.
ClinicalTrials.gov Identifier:
NCT01286935
First received: August 23, 2010
Last updated: January 28, 2011
Last verified: January 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Levodopa
U.S. FDA Resources

Further study details as provided by Newron Pharmaceuticals S.p.A.:

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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    • 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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286935

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr Ravi Anand (Chief Medical Officer), Newron Pharmaceuticals S.p.A.
ClinicalTrials.gov Identifier: NCT01286935     History of Changes
Other Study ID Numbers: NW-1015/018/III/2006, 2006-005861-21
Study First Received: August 23, 2010
Last Updated: January 28, 2011
Health Authority: India: Drugs Controller General of India
Romania: National Medicines Agency
Italy: Ministry of Health

Keywords provided by Newron Pharmaceuticals S.p.A.:
Parkinson's Disease
PD
Levodopa
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

ClinicalTrials.gov processed this record on June 18, 2013