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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286935
• Other study ID #: NW-1015/018/III/2006
• Secondary ID: 2006-005861-21
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2010
• Last updated: January 28, 2011
• Start date: August 2007
• Est. completion date: August 2010

Study information

• Verified date: January 2011
• Source: Newron
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 544
• Est. completion date: August 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Safinamide

• Safinamide

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Newron

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in the dyskinesias rating scale (DRS) during "on" time	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	Endpoints include 'ON time', responder rates and UPDRS IV change	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)

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