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Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Carbidopa/levodopa/entacapone
Immediate release carbidopa/levodopa
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Idiopathic Parkinson's disease, carbidopa/levodopa/entacapone, non-motor symptoms, motor-symptoms

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be aged 30 to 85 years.
  • Be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol.
  • Have a clinical diagnosis of idiopathic Parkinson's Disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia)
  • Have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of Parkinson's Disease which improves with the next immediate release (IR) carbidopa/levodopa dose as determined by the Quantitative Wearing-Off Questionnaire 9 and investigator's assessment. At least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (IR) carbidopa/levodopa administration. Also there should not have been a deterioration of 1 point or more in another non-motor item.(all criteria must be fulfilled)
  • Be taking a stable dose of immediate release (IR) carbidopa/levodopa for at least 21 days prior to randomization at an equivalent total daily dose of immediate release (IR) carbidopa/levodopa between 300 to 800 mg. Dosing should be either 3 to 6 times per day.

Exclusion Criteria:

  • Have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization;
  • Have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism;
  • Have unstable Parkinson's Disease requiring frequent booster doses;
  • Disabling dyskinesias, indicated by a score of greater than 1 on Unified Parkinson Disease Rating Scale question #32, or a score of greater than 1 on Unified Parkinson Disease Rating Scale question #33;
  • Have a history or current diagnosis of psychotic features according to the investigator;

Other protocol-defined inclusion/exclusion criteria applied to the study.

Sites / Locations

  • Xenoscience, Inc
  • South Coast Health Center
  • University of California
  • Coastal Neurological Medical Group, Inc
  • Georgetown University Hospital
  • Sunrise Clinical Research, Inc
  • Charlotte Neurological Services
  • Cotton O'Neil Clinic
  • University of Maryland School of Medicine
  • Neurology, Inc
  • Dr. John's Mercy Medical Center
  • Creighton U Medical Center, Dept of Neurology
  • Parkinson's Disease & Movement Disorders
  • Central New York Research Corporation
  • Neurological Care of Central NY
  • Duke University
  • Neurology Associates
  • University of Pittsburg
  • University of Texas Southwestern
  • University of Texas Medical School
  • Scott & White Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carbidopa/levodopa/entacapone

Immediate release carbidopa/levodopa

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from "not present" to "very severe". The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement.

Secondary Outcome Measures

Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 5 motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from "not present" to "very severe". The range of possible score values of the motor subscale of the QWOQ-9 is 0 to 20. A higher score indicates greater disability. A negative change score indicates improvement.

Full Information

First Posted
March 19, 2008
Last Updated
February 16, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00642356
Brief Title
Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off
Official Title
An 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Idiopathic Parkinson's disease, carbidopa/levodopa/entacapone, non-motor symptoms, motor-symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbidopa/levodopa/entacapone
Arm Type
Experimental
Arm Title
Immediate release carbidopa/levodopa
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Carbidopa/levodopa/entacapone
Other Intervention Name(s)
Stalevo®
Intervention Description
Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
Intervention Type
Drug
Intervention Name(s)
Immediate release carbidopa/levodopa
Intervention Description
Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
Primary Outcome Measure Information:
Title
Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
Description
The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from "not present" to "very severe". The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement.
Time Frame
Baseline to 15 minutes prior to 2nd dose at Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
Description
The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 5 motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from "not present" to "very severe". The range of possible score values of the motor subscale of the QWOQ-9 is 0 to 20. A higher score indicates greater disability. A negative change score indicates improvement.
Time Frame
Baseline to 15 minutes prior to 2nd dose at Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be aged 30 to 85 years. Be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol. Have a clinical diagnosis of idiopathic Parkinson's Disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia) Have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of Parkinson's Disease which improves with the next immediate release (IR) carbidopa/levodopa dose as determined by the Quantitative Wearing-Off Questionnaire 9 and investigator's assessment. At least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (IR) carbidopa/levodopa administration. Also there should not have been a deterioration of 1 point or more in another non-motor item.(all criteria must be fulfilled) Be taking a stable dose of immediate release (IR) carbidopa/levodopa for at least 21 days prior to randomization at an equivalent total daily dose of immediate release (IR) carbidopa/levodopa between 300 to 800 mg. Dosing should be either 3 to 6 times per day. Exclusion Criteria: Have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization; Have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism; Have unstable Parkinson's Disease requiring frequent booster doses; Disabling dyskinesias, indicated by a score of greater than 1 on Unified Parkinson Disease Rating Scale question #32, or a score of greater than 1 on Unified Parkinson Disease Rating Scale question #33; Have a history or current diagnosis of psychotic features according to the investigator; Other protocol-defined inclusion/exclusion criteria applied to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Xenoscience, Inc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
South Coast Health Center
City
Aliso Viejo
State/Province
California
ZIP/Postal Code
92656
Country
United States
Facility Name
University of California
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Coastal Neurological Medical Group, Inc
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Sunrise Clinical Research, Inc
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Charlotte Neurological Services
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Cotton O'Neil Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Neurology, Inc
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Dr. John's Mercy Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Creighton U Medical Center, Dept of Neurology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Parkinson's Disease & Movement Disorders
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Central New York Research Corporation
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Neurological Care of Central NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Neurology Associates
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
University of Pittsburg
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott & White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off

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