NCT00237263

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

4.4 years

First QC Date

October 7, 2005

Last Update Submit

January 10, 2024

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, end-of -dose wearing-off, entacapone

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (2)

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

  • UPDRS score at every 16 weeks

Interventions

EntacaponeDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Serious heart, pulmonary, renal, hepatic or gastrointestinal disease
  • Dementia symptoms
  • Pregnant or nursing (lactating) women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

entacapone

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

February 1, 2003

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 11, 2024

Record last verified: 2024-01

Locations

US(1)