Clinical trial NCT00642356: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Idiopathic Parkinson's disease
carbidopa/levodopa/entacapone
non-motor symptoms
motor-symptoms
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
timeFrame: Baseline to 15 minutes prior to 2nd dose at Week 8
Secondary outcomes:
measure: Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
timeFrame: Baseline to 15 minutes prior to 2nd dose at Week 8
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Xenoscience, Inc
state: Arizona
city: Aliso Viejo
country: United States
facility: South Coast Health Center
state: California
city: Irvine
country: United States
facility: University of California
state: California
city: La Jolla
country: United States
facility: Coastal Neurological Medical Group, Inc
state: California
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Hollywood
country: United States
facility: Sunrise Clinical Research, Inc
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Neurological Services
state: Florida
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Columbia
country: United States
facility: Neurology, Inc
state: Missouri
city: St. Louis
country: United States
facility: Dr. John's Mercy Medical Center
state: Missouri
city: Omaha
country: United States
facility: Creighton U Medical Center, Dept of Neurology
state: Nebraska
city: Commack
country: United States
facility: Parkinson's Disease & Movement Disorders
state: New York
city: Syracuse
country: United States
facility: Central New York Research Corporation
state: New York
city: Syracuse
country: United States
facility: Neurological Care of Central NY
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Monroeville
country: United States
facility: Neurology Associates
state: Pennsylvania
city: Pittsburg
country: United States
facility: University of Pittsburg
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: University of Texas Medical School
state: Texas
city: Temple
country: United States
facility: Scott & White Hospital
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: