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

NCT ID: NCT00642356

Last Updated: 2011-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-05-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Carbidopa/levodopa/entacapone

Group Type: EXPERIMENTAL

Carbidopa/levodopa/entacapone

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Immediate release carbidopa/levodopa

Intervention Type: DRUG

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.

Interventions

Carbidopa/levodopa/entacapone

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

Immediate release carbidopa/levodopa

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.

Intervention Type: DRUG

Other Intervention Names

Stalevo®

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;

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Xenoscience, Inc

Phoenix, Arizona, United States

South Coast Health Center

Aliso Viejo, California, United States

University of California

Irvine, California, United States

Coastal Neurological Medical Group, Inc

La Jolla, California, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Sunrise Clinical Research, Inc

Hollywood, Florida, United States

Charlotte Neurological Services

Port Charlotte, Florida, United States

Cotton O'Neil Clinic

Topeka, Kansas, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

Neurology, Inc

Columbia, Missouri, United States

Dr. John's Mercy Medical Center

St Louis, Missouri, United States

Creighton U Medical Center, Dept of Neurology

Omaha, Nebraska, United States

Parkinson's Disease & Movement Disorders

Commack, New York, United States

Central New York Research Corporation

Syracuse, New York, United States

Neurological Care of Central NY

Syracuse, New York, United States

Duke University

Durham, North Carolina, United States

Neurology Associates

Monroeville, Pennsylvania, United States

University of Pittsburg

Pittsburgh, Pennsylvania, United States

University of Texas Southwestern

Dallas, Texas, United States

University of Texas Medical School

Houston, Texas, United States

Scott & White Hospital

Temple, Texas, United States

Countries

United States

Other Identifiers

CELC200AUS14

Identifier Type: -

Identifier Source: org_study_id