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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

NCT ID: NCT01286935

Last Updated: 2011-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

544 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low Dose (50mg/day)

Group Type EXPERIMENTAL

Safinamide

Intervention Type DRUG

High Dose (100mg/day)

Group Type EXPERIMENTAL

Safinamide

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Safinamide

Intervention Type DRUG

Safinamide

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Newron Pharmaceuticals SPA

INDUSTRY

Sponsor Role lead

Responsible Party

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Newron Pharmaceuticals S.p.A.

Principal Investigators

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See Study 016 for details

Role: PRINCIPAL_INVESTIGATOR

PI's are the same as for study NW-1015/016/III/2006

Related Links

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http://www.newron.com/

Related Info

Other Identifiers

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2006-005861-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NW-1015/018/III/2006

Identifier Type: -

Identifier Source: org_study_id