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

NCT01286935 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2011-01-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Safinamide

DRUG

Safinamide

DRUG

Placebo

Sponsors & Collaborators

  • Newron Pharmaceuticals SPA

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-04-30
Completion
2010-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01286935 on ClinicalTrials.gov