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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Safinamide

Drug

Placebo

Drug

Primary outcomes

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 outcomes

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)

Sponsors and collaborators

Lead sponsor

Newron Pharmaceuticals SPA

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Jan 31, 2011
Registry last updated: Jan 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed