Not Signed In -
Ethosuximide Capsules |
Zarontin |
Clinical Trial: A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Vs. Immediate Release Carbidopa/Levodopa
This study is not yet open for patient recruitment.
Verified by Novartis July 2005
|
Purpose
To achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson’s disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level 100 mg t.i.d.
| Condition | Intervention | Phase |
|---|---|---|
| Parkinson''''s Disease | Drug: capsules containing: carbidopa 25 mg, levodopa 100 mg, entacapone 200 mg | Phase III |
MedlinePlus related topics: Parkinson''''s Disease
Genetics Home Reference related topics: Parkinson disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 Mg t.i.d. Vs. Immediate Release Carbidopa/Levodopa 25/100 Mg (t.i.d.) in Parkinson''''s Disease Patients Requiring Levodopa
Further Study Details:
Expected Total Enrollment: 424
Study start: August 2005
To achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson’s disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level 100 mg t.i.d.
Eligibility
Ages Eligible for Study: 30 Years - 80 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Aged 30 to 80 years, inclusive, at time of Parkinson’s disease diagnosis
- Idiopathic Parkinson''''s disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia or rigidity
- Parkinson''''s disease impairment warranting treatment with a levodopa formulation according to the investigator''''s assessment
Exclusion Criteria:
- History, signs or symptoms suggesting the diagnosis of atypical or secondary Parkinsonism due to drugs, metabolic disorders, encephalitis or other neurodegenerative diseases
- History of stereotaxic brain surgery for PD (e.g., pallidotomy, deep brain stimulation, tissue transplant)
- Diagnosis of Parkinson''''s disease for more than 5 years prior to Screening
- Previous use of levodopa in any formulation, entacapone or tolcapone for more than 30 days or anytime within 4 weeks(28 days) prior to baseline
- Use of a dopamine agonist within 4 weeks(28 days) prior to baseline
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00134966
Novartis Pharmaceuticals 862-778-8300
California
Stanford University Medical Center, Department of Neurology, 300 Pasteur Drive, Room A343, Stanford, California, 94305, United States
650-724-2541
Helen Bronte-Stewart, MD, MSE, Principal Investigator
Helen Bronte-Stewart, MD, MSE, Principal Investigator
Coastal Neurological Medical Group, Inc, 9850 Genesee Avenue, Suite 740, La Jolla, California, 92037, United States
858-535-9390
Dee Silver, MD, Principal Investigator
Dee Silver, MD, Principal Investigator
UC Davis Medical Center, Department of Neurology, 4860 Y Street, Suite 0100, Sacramento, California, 95817, United States
916-734-6225
Lin Zhang, MD, PhD, Principal Investigator
Lin Zhang, MD, PhD, Principal Investigator
Florida
University of Florida Health Science Center, 580 West 8th Street, Tower 1, 9th Floor, Jacksonville, Florida, 32209, United States
904-244-9480
Zhigao Huang, MD, PhD, Principal Investigator
Zhigao Huang, MD, PhD, Principal Investigator
Mayo Clinic, 4500 San Pablo Road, Jacksonville, Florida, 32224, United States
904-953-0758
Ryan Uitti, MD, Principal Investigator
Ryan Uitti, MD, Principal Investigator
USF Medical Clinic, 12901 Bruce B. Downs Blvd., MDC 55, Tampa, Florida, 33612, United States
813-974-8032
Theresa Zesiewicz, MD, Principal Investigator
Theresa Zesiewicz, MD, Principal Investigator
Ohio
The Cleveland Clinic Foundation, 2645 Wakefield Lane, Westlake, Ohio, 44145, United States
216-445-7340
Thyagaraj Subramanian, MD, Principal Investigator
Thyagaraj Subramanian, MD, Principal Investigator
Melbourne Internal Medicine Associates, 2645 Wakefield Lane, Westlake, Ohio, 44145, United States
321-725-7028
William Sunter, Jr., MD, Principal Investigator
William Sunter, Jr., MD, Principal Investigator
Pennsylvania
Lankenau Hospital, 100 Lancaster Avenue, Suite 161 E, Wynnewood, Pennsylvania, 19096-3425, United States
610-642-5658
Stephen Gollomp, MD, Principal Investigator
Stephen Gollomp, MD, Principal Investigator
South Carolina
Coastal Neurology, PA, 989 Ribant Road, Suite 310 Beufort, South Carolina, 29902, United States
843-522-1460
Paul Mazzeo, MD, Principal Investigator
Paul Mazzeo, MD, Principal Investigator
Texas
Neurology Associates, 1341 Thorpe Lane, San Marcos, Texas, 78666, United States
512-558-7773
Eric Pappert, MD, Principal Investigator
Eric Pappert, MD, Principal Investigator
Canada
University of Saskatchewan, Royal University Hospital, 103 Hopital Drive, Room 1659, Saskatoon, S7N 0W8, Canada
306-966-8030
Alexander Rajput, MD, FRCPC, Principal Investigator
Alexander Rajput, MD, FRCPC, Principal Investigator
Canada, Alberta
Heritage Medical Research Clinic, 3350 Hospital Drive NW, Suite 1140, Calgary, Alberta, T2N 4N1, Canada
403-283-2907
Scott Kraft, MSC, MD, BSC, FRCP(C), Principal Investigator
Scott Kraft, MSC, MD, BSC, FRCP(C), Principal Investigator
Canada, Nova Scotia
Cape Breton Regional Hospital, Neurology Department, 1482 George Street, Sydney, Nova Scotia, B1P 1P3, Canada
902-567-8126
Richard Leckey, BSC, MD, FRCPC, Principal Investigator
Richard Leckey, BSC, MD, FRCPC, Principal Investigator
Canada, Ontario
Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Room D715, 7th Floor, Ottawa, Ontario, K1Y 4E9, Canada
613-761-5353 Ext. 2
David Grimes, MD, Principal Investigator
David Grimes, MD, Principal Investigator
Centre for Movements Disorders, 2780 Bur Oak Avenue, Markham, Ontario, L6B 1C9, Canada
905-472-6270
Mark Guttman, MD, FRCPC, Principal Investigator
Mark Guttman, MD, FRCPC, Principal Investigator
Canada, Quebec
Montreal General Hospital, 1650 Cedar Avenue, Room L 7 107, Montreal, Quebec, H3G 1A4, Canada
514-934-8265
Anne-Louise Lafontaine, MD, MSC, Principal Investigator
Anne-Louise Lafontaine, MD, MSC, Principal Investigator
Unite des Troubles du Mouvement Andre-Barbeau, CHUM-Hotel-Dieu, 3840 St-Urbain, Bur. 7-561, Montreal, Quebec, Canada
Michel Panisset, Principal Investigator
Quebec Memory and Motor Skills Disorders Clinic, 65 Sainte-Anne, Price Building, 3rd Floor, Quebec, Quebec, G1R 3X5, Canada
418-692-3338
Emmanuelle Pourcher, MD, MSC, FRCP(C), Principal Investigator
Emmanuelle Pourcher, MD, MSC, FRCP(C), Principal Investigator
Centre de Recjerche Clinique du CHUS, 3001 12th Avenue Nord, Sherbrooke, Quebec, J1H 5N4, Canada
819-346-1110
Jean Rivest, MD, Principal Investigator
Jean Rivest, MD, Principal Investigator
More Information
Study ID Numbers: CELC200A2305
Last Updated: August 24, 2005
Record first received: August 23, 2005
ClinicalTrials.gov Identifier: NCT00134966
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
Last Updated: August 24, 2005
Record first received: August 23, 2005
ClinicalTrials.gov Identifier: NCT00134966
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
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