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A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease

NCT01211587 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2013-03-29

No results posted yet for this study

Summary

The purpose of this research trial is to determine if safinamide (experimental drug) can improve cognition in cognitively impaired but non-demented Parkinson's disease patients. The word "experimental" means the trial drug is not approved by Health Authorities (government authorities) and is still being tested for safety and effectiveness.

Approximately one hundred (100) patients will participate in this research trial. The research trial will be conducted in approximately thirty (30) medical centers in the following countries: Argentina, Canada, Italy, Peru, South Africa, Spain and USA. The research trial will last until June 2012.

Conditions

  • Parkinson's Disease With Cognitive Impairments

Interventions

DRUG

safinamide

Safinamide will be provided in tablets equivalent to 50 mg in blisters. After randomization, patients receiving safinamide will take two 50 mg tablets once per day for 12 weeks (weeks 1-12). During the open label phase, patients will receive 100mg of safinamide once per day (two 50 mg tablets) for 12 weeks (weeks 13-24).

DRUG

placebo

Identical placebo tablets will be provided in blisters. After randomization, patients receiving placebo will take two tablets once per day for 12 weeks (weeks 1-12). During the open label phase, patients will receive 100mg of safinamide once per day (two 50 mg tablets) for 12 weeks (weeks 13-24).

Sponsors & Collaborators

  • Newron Pharmaceuticals SPA

    lead INDUSTRY

Principal Investigators

  • Jonathan Willmer, MD, FRCPC · Merck Serono S.A., Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-04-30

Countries

  • United States
  • Spain

Study Locations

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Entities

Drugs

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 NCT01211587 on ClinicalTrials.gov