18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD

January 28, 2011 updated by: Newron Pharmaceuticals SPA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

544

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Low Dose (50mg/day)
Drug: Safinamide
Experimental: High Dose (100mg/day)
Drug: Safinamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 104 weeks (from baseline 016 to EOS study 018)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 104 weeks (from baseline 016 to EOS study 018)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newron Pharmaceuticals SPA

Investigators

  • Principal Investigator: See Study 016 for details, PI's are the same as for study NW-1015/016/III/2006

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

January 28, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 28, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NW-1015/018/III/2006
  • 2006-005861-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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