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

PHASE4TerminatedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Parkinson's Disease
Interventions
DRUG

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.

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.

Trial Locations (21)

11725

Parkinson's Disease & Movement Disorders, Commack

13210

Central New York Research Corporation, Syracuse

Neurological Care of Central NY, Syracuse

15146

Neurology Associates, Monroeville

15213

University of Pittsburg, Pittsburgh

20007

Georgetown University Hospital, Washington D.C.

21201

University of Maryland School of Medicine, Baltimore

27705

Duke University, Durham

33021

Sunrise Clinical Research, Inc, Hollywood

33952

Charlotte Neurological Services, Port Charlotte

63141

Dr. John's Mercy Medical Center, St Louis

65201

Neurology, Inc, Columbia

66606

Cotton O'Neil Clinic, Topeka

68131

Creighton U Medical Center, Dept of Neurology, Omaha

75390

University of Texas Southwestern, Dallas

76508

Scott & White Hospital, Temple

77030

University of Texas Medical School, Houston

85004

Xenoscience, Inc, Phoenix

92037

Coastal Neurological Medical Group, Inc, La Jolla

92656

South Coast Health Center, Aliso Viejo

92697

University of California, Irvine

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY

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 | Biotech Hunter | Biotech Hunter