Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-27 @ 7:07 PM
Study NCT ID:
NCT00134966
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2005-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020820', 'term': 'Dyskinesias'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007980', 'term': 'Levodopa'}, {'id': 'C071192', 'term': 'entacapone'}, {'id': 'C481098', 'term': 'Stalevo'}], 'ancestors': [{'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014443', 'term': 'Tyrosine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 493}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2005-08-23', 'studyFirstSubmitQcDate': '2005-08-23', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom control change from baseline to week 39'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to week 39 in activities of daily living'}, {'measure': 'Change from baseline to week 39 in motor function'}, {'measure': 'Change from baseline to week 39 in mental acuity'}, {'measure': 'Change from baseline to week 39 in incidence of dyskinesia and wearing off'}]}, 'conditionsModule': {'keywords': ["Parkinson's disease, levodopa, dyskinesia"], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '19058133', 'type': 'DERIVED', 'citation': "Hauser RA, Panisset M, Abbruzzese G, Mancione L, Dronamraju N, Kakarieka A; FIRST-STEP Study Group. Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease. Mov Disord. 2009 Mar 15;24(4):541-50. doi: 10.1002/mds.22343."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is 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 of 100 mg three times a day (t.i.d.).", 'detailedDescription': "The purpose of this study is 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 30 to 80 years, inclusive, at time of Parkinson's disease diagnosis\n* Idiopathic Parkinson's disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia or rigidity\n* Parkinson's disease impairment warranting treatment with a levodopa formulation according to the investigator's assessment\n\nExclusion Criteria:\n\n* History, signs or symptoms suggesting the diagnosis of atypical or secondary Parkinsonism due to drugs, metabolic disorders, encephalitis or other neurodegenerative diseases\n* History of stereotaxic brain surgery for PD (e.g., pallidotomy, deep brain stimulation, tissue transplant)\n* Diagnosis of Parkinson's disease for more than 5 years prior to Screening\n* 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\n* Use of a dopamine agonist within 4 weeks (28 days) prior to baseline"}, 'identificationModule': {'nctId': 'NCT00134966', 'briefTitle': 'A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'CELC200A2305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)']}], 'interventions': [{'name': 'capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)', 'type': 'DRUG', 'otherNames': ['Stalevo', 'CELC200'], 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Coastal Neurological Medical Group, Inc', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91335', 'city': 'Reseda', 'state': 'California', 'country': 'United States', 'facility': 'Neurosearch, Inc.', 'geoPoint': {'lat': 34.20112, 'lon': -118.53647}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Science Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF Medical Clinic', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '01104', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Springfield Neurology Associates, LLC', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '48034', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Neuroscience Center', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'country': 'United States', 'facility': 'Melbourne Internal Medicine Associates', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}, {'zip': '15601', 'city': 'Greensburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Westmoreland Neurology Associates, Inc.', 'geoPoint': {'lat': 40.30146, 'lon': -79.53893}}, {'zip': '19096-3425', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lankenau Hospital', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'NeuroHealth', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29902', 'city': 'Beaufort', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Neurology, PA', 'geoPoint': {'lat': 32.4317, 'lon': -80.66993}}, {'zip': '78757', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Senior Adults Specialty Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Baylor College of Medicine, Parkinson's Disease Center", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78666', 'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'Neurology Associates', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Blue Ridge Research Center at Roanoke Neurological Center', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Heritage Medical Research Clinic', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'E1C 2M4', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'A1B 3V6', 'city': "HSC Room 5317, 300 Prince Philip Drive, Saint John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Eastern Health Care - Health Sciences Centre, Neurology Department', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3J 3T1', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Neurology Division, Health Science Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'B1P 1P3', 'city': 'Sydney', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Cape Breton Regional Hospital, Neurology Department', 'geoPoint': {'lat': 46.1351, 'lon': -60.1831}}, {'zip': 'N2H 5Z8', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Grand River Hospital', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Center, University Hospital, Rm. A10-026', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L6B 1C9', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Movement Disorders', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'K1G 4G3', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': "Parkinson's & Neurodegenerative Disorders Clinic", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital, Civic Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'N8X 5A6', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hiren Desai Medicine Professional Corporation', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'J4V 2J2', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Neuro Rive Sud', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Unite des Troubles du Mouvement Andre-Barbeau, CHUM-Hotel-Dieu', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Recjerche Clinique du CHUS', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'S4T 1A5', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Dr. Felix Veloso Research', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'zip': 'G1R 3X5', 'city': 'Québec', 'country': 'Canada', 'facility': 'Quebec Memory and Motor Skills Disorders Clinic', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'S7N 0W8', 'city': 'Saskatoon', 'country': 'Canada', 'facility': 'University of Saskatchewan, Royal University Hospital', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': '775 20', 'city': 'I.P.Pavlova 6', 'state': 'Olomouc', 'country': 'Czechia', 'facility': 'Neurologická klinika, Univerzita Palackého'}, {'zip': '304 60', 'city': 'Alej Svobody 80', 'state': 'Plzeň', 'country': 'Czechia', 'facility': 'FN-neurologická klinika'}, {'zip': '12000', 'city': 'Katerinska 12, Praha 2', 'country': 'Czechia', 'facility': 'Neurologicka klinika', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '53000', 'city': 'Kyjevska 44, Pardubice', 'country': 'Czechia', 'facility': 'FN-Nemocnice Pardubice', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '31096', 'city': 'Haliya Hashniya 8', 'state': 'Haifa District', 'country': 'Israel', 'facility': 'Rambam Medical Center'}, {'zip': '70300', 'city': 'Dep. of Neurology, Zerifin', 'country': 'Israel', 'facility': 'Dep. Of Neurology (Bitan 38, EEG institute)', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Belinson Campus, Jabotinsky st. Movement Disorder Unit', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '64239', 'city': 'Weitzman Saint Movement Disorder Clinic, Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '95123', 'city': 'Via Santa Sofia 78', 'state': 'Catania', 'country': 'Italy', 'facility': 'Clinica Neurologica I - Azienda Ospedaliera-Universitaria Policlinico - Università di Catania'}, {'zip': '16132', 'city': 'Università Degli Studi Di Genova, Via de Toni 5', 'state': 'Genova', 'country': 'Italy', 'facility': '"Dipartimento di Neuroscienze Oftalmologia e Genetica (DINOG)'}, {'zip': '98125', 'city': 'Via Consolare Valeria', 'state': 'Messina', 'country': 'Italy', 'facility': 'Unità Operativa Complessa Neurologia - Policlinico Universitario "G. Martino"'}, {'zip': '20100', 'city': 'Via Celoria 11', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Nazionale Neurologico "Carlo Besta"'}, {'zip': '56127', 'city': 'Via Roma, 67', 'state': 'Pisa', 'country': 'Italy', 'facility': 'Dipartimento di Neuroscienze-Sezione Neurologia Università degli Studi di Pisa- AO S. Chiara'}, {'zip': '00185', 'city': "Viale dell'Università 30", 'state': 'Roma', 'country': 'Italy', 'facility': 'Dipartimento di Scienze Neurologiche Università degli Studi di Roma "La Sapienza" Roma I'}, {'zip': '10126', 'city': 'Via Cherasco 15', 'state': 'Torino', 'country': 'Italy', 'facility': 'Dipartimento di Neuroscienze-Università degli Studi di Torino'}, {'zip': '20126', 'city': 'Via Bignami 1, Milan', 'country': 'Italy', 'facility': "A.O. Istituti Clinici di Perfezionamento-Unita'Operativa Centro Parkinson", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00-416', 'city': 'Ul. Czerniakowska 231, Warszawa', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny Oddzial Kliniczny Neurologii i Epiletologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '31-530', 'city': 'Ul. Dwernickiego 8, Krakow', 'country': 'Poland', 'facility': 'Centrum Neurologii Klinicznej', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '40-752', 'city': 'ul.Medykow 14, Katowice', 'country': 'Poland', 'facility': 'Klinika Neruologii Wieku Podeszlego', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '3000-075', 'city': 'Avenida Bissaya Barreto, Coimbra', 'country': 'Portugal', 'facility': 'Hospitais da Universidade de Coimbra (Serv. Neurologia)', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '1649-035', 'city': 'Avenida Professor Egas Moniz, Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Maria (Serv. Neurologia)', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4099-001', 'city': 'Largo Professor Abel Salazar, Porto', 'country': 'Portugal', 'facility': 'Hospital de Santo António (Serv. Neurologia)', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '34610', 'city': 'Istanbul University CAPA Medical School, Dept. of Neurology', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul CAPA Medical School'}, {'zip': '6,100', 'city': 'Hacettepe Universitesi Hastaneleri Norooji AD Sihhiye, Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe Medical School, Department of Neurology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '35340', 'city': 'Noroloji Anabilim Dali Inciralti Izmir, Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylul Medical School, Department of Neurology', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}