An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United States

NCT ID: NCT00237263

Last Updated: 2024-01-11

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

PHASE2

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2007-07-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.

This study is not recruiting patients in the United States.

Detailed Description

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The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Entacapone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Attended the Phase IIb study
* Able to fill out the patient diary

Exclusion Criteria

* Serious heart, pulmonary, renal, hepatic or gastrointestinal disease
* Dementia symptoms
* Pregnant or nursing (lactating) women
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CCOM998A1204

Identifier Type: -

Identifier Source: org_study_id

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