Clinical trial

An Extension Study to Phase IIb Dose-finding Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off

Name

CCOM998A1204

Description

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.

Trial arms

Trial start

2003-02-01

Estimated PCD

2007-07-01

Trial end

2007-07-01

Status

Completed

Phase

Early phase I

Treatment

Entacapone

Size

285

Primary endpoint

Incidence of adverse events during the long term treatment (maximum 3 years)

Blood pressure at every 12 weeks

Laboratory test at every 16 weeks

ECG at every 16 weeks

Eligibility criteria

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 Other protocol-defined inclusion/exclusion criteria may apply.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 285, 'type': 'ACTUAL'}}

Updated at

2024-01-11

1 organization

1 product

1 indication

Product

Entacapone

Indication

Parkinson's Disease

Organization

Novartis