Study Stopped
slow enrollment
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
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
1 other identifier
interventional
14
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2008
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
January 11, 2011
CompletedFebruary 18, 2011
February 1, 2011
1.2 years
March 19, 2008
December 14, 2010
February 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 15 minutes prior to 2nd dose at Week 8
Secondary Outcomes (1)
Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
Baseline to 15 minutes prior to 2nd dose at Week 8
Study Arms (2)
Carbidopa/levodopa/entacapone
EXPERIMENTALImmediate release carbidopa/levodopa
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (21)
Xenoscience, Inc
Phoenix, Arizona, 85004, United States
South Coast Health Center
Aliso Viejo, California, 92656, United States
University of California
Irvine, California, 92697, United States
Coastal Neurological Medical Group, Inc
La Jolla, California, 92037, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Sunrise Clinical Research, Inc
Hollywood, Florida, 33021, United States
Charlotte Neurological Services
Port Charlotte, Florida, 33952, United States
Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Neurology, Inc
Columbia, Missouri, 65201, United States
Dr. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Creighton U Medical Center, Dept of Neurology
Omaha, Nebraska, 68131, United States
Parkinson's Disease & Movement Disorders
Commack, New York, 11725, United States
Central New York Research Corporation
Syracuse, New York, 13210, United States
Neurological Care of Central NY
Syracuse, New York, 13210, United States
Duke University
Durham, North Carolina, 27705, United States
Neurology Associates
Monroeville, Pennsylvania, 15146, United States
University of Pittsburg
Pittsburgh, Pennsylvania, 15213, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
University of Texas Medical School
Houston, Texas, 77030, United States
Scott & White Hospital
Temple, Texas, 76508, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 25, 2008
Study Start
March 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
February 18, 2011
Results First Posted
January 11, 2011
Record last verified: 2011-02