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Completed

NCT Number: NCT00237263

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Entacapone

Drug

Primary outcomes

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

  2. Blood pressure at every 12 weeks

  3. Laboratory test at every 16 weeks

  4. ECG at every 16 weeks

Secondary outcomes

  1. On time based on patient diary (up to 104 weeks)

  2. UPDRS score at every 16 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Oct 12, 2005
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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