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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01286935

Enrollment

544

Registered

2011-01-31

Start date

2007-08-31

Completion date

2010-08-31

Last updated

2011-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease, PD, Levodopa, Patients with idiopathic Parkinson's Disease with motor fluctuations,

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.

Interventions

DRUGSafinamide

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026