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

Sponsor

Newron Pharmaceuticals SPA (Industry)

Overall Status

Completed

CT.gov ID

NCT01286935

Collaborator

(none)

544

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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: Safinamide Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

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 :

Aug 1, 2007

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Low Dose (50mg/day)

Drug: Safinamide

Experimental: High Dose (100mg/day)

Drug: Safinamide

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Mean change in the dyskinesias rating scale (DRS) during "on" time [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 [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

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Newron Pharmaceuticals SPA

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01286935

Other Study ID Numbers:

NW-1015/018/III/2006
2006-005861-21

First Posted:

Jan 31, 2011

Last Update Posted:

Jan 31, 2011

Last Verified:

Jan 1, 2011

Keywords provided by , ,

Parkinson's Disease

Levodopa

Patients with idiopathic Parkinson's Disease with motor fluctuations,

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Jan 31, 2011