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

Phase 4

Terminated

Conditions: Parkinson's Disease

Interventions: Drug: Carbidopa/levodopa/entacapone
Drug: Immediate release carbidopa/levodopa

Registration Number: NCT00642356

Lead Sponsor: Novartis

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 14

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbidopa/levodopa/entacapone	Carbidopa/levodopa/entacapone	-
Immediate release carbidopa/levodopa	Immediate release carbidopa/levodopa	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)	Baseline to 15 minutes prior to 2nd dose at Week 8	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

Name	Time	Method
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	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.

Trial Locations

Locations (21): University of California
🇺🇸
Irvine, California, United States
Central New York Research Corporation
🇺🇸
Syracuse, New York, United States
Sunrise Clinical Research, Inc
🇺🇸
Hollywood, Florida, United States
Dr. John's Mercy Medical Center
🇺🇸
St. Louis, Missouri, United States
Neurological Care of Central NY
🇺🇸
Syracuse, New York, United States
University of Texas Southwestern
🇺🇸
Dallas, Texas, United States
South Coast Health Center
🇺🇸
Aliso Viejo, California, United States
Neurology Associates
🇺🇸
Monroeville, Pennsylvania, United States
Charlotte Neurological Services
🇺🇸
Port Charlotte, Florida, United States
University of Maryland School of Medicine
🇺🇸
Baltimore, Maryland, United States
Coastal Neurological Medical Group, Inc
🇺🇸
La Jolla, California, United States
Cotton O'Neil Clinic
🇺🇸
Topeka, Kansas, United States
Neurology, Inc
🇺🇸
Columbia, Missouri, United States
Georgetown University Hospital
🇺🇸
Washington, District of Columbia, United States
Parkinson's Disease & Movement Disorders
🇺🇸
Commack, New York, United States
Scott & White Hospital
🇺🇸
Temple, Texas, United States
Xenoscience, Inc
🇺🇸
Phoenix, Arizona, United States
Creighton U Medical Center, Dept of Neurology
🇺🇸
Omaha, Nebraska, United States
Duke University
🇺🇸
Durham, North Carolina, United States
University of Pittsburg
🇺🇸
Pittsburg, Pennsylvania, United States
University of Texas Medical School
🇺🇸
Houston, Texas, United States