Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT00736151
Status:
COMPLETED
Last Update Posted:
2009-08-07
First Post:
2008-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Dose Titration Study in Patients With Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C499681', 'term': 'Ralfinamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'lastUpdateSubmitDate': '2009-08-06', 'studyFirstSubmitDate': '2008-08-13', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2009-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of pain intensity', 'timeFrame': 'Baseline to week 8 or last visit'}], 'secondaryOutcomes': [{'measure': 'The incidence of adverse events', 'timeFrame': 'From baseline to week 8 or last visit'}]}, 'conditionsModule': {'conditions': ['Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients\n* Females post-menopausal for at least 12 months, 24 months in India, Poland, and Austria\n* Diagnosed by neurologist with current neuropathic pain\n\nExclusion Criteria:\n\n* See inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00736151', 'briefTitle': 'Phase II Dose Titration Study in Patients With Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Newron Pharmaceuticals SPA'}, 'officialTitle': 'A Phase II, Multicentre, Pilot, Randomised, Double Blind Placebo Controlled Dose Titration Study to Evaluate the Safety, Maximum Tolerated Dose and Preliminary Evidence of Efficacy of Orally Administered Ralfinamide at Four Doses (80, 160, 240 and 320 mg/Day) in Patients With Neuropathic Pain', 'orgStudyIdInfo': {'id': 'NW-1029/001/II/2003'}, 'secondaryIdInfos': [{'id': 'EUDRACT Number 2004-000557-35'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Ralfinamide administered orally at rising doses of 80 - 320 mg/day', 'interventionNames': ['Drug: Ralfinamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Placebo controlled with randomization of 2:1', 'interventionNames': ['Drug: Ralfinamide']}], 'interventions': [{'name': 'Ralfinamide', 'type': 'DRUG', 'description': 'Oral tablets administered at rising doses of 80 - 320 mg/day', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Universitatsklinik Fur Neurologie', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Universitatsklinik Fur Neurologie', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Klagenfurt', 'country': 'Austria', 'facility': 'LKH', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'General Hospital AKH', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Brno', 'country': 'Czechia', 'facility': "Fakultni nemocnice u svate' Anny v Brne", 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Brno-Bhunice', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Brno'}, {'city': 'Olomouc', 'country': 'Czechia', 'facility': 'University Hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Pizen', 'country': 'Czechia', 'facility': 'Univercity Hospital Pilsen'}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Fakultni Thomayerova nemocnices poliklinikou', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Na Homolce Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Ahmedabad', 'country': 'India', 'facility': 'Neurology Centre', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'M.S. 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S.I. Fondazione Universitaria', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'city': 'Chieti', 'country': 'Italy', 'facility': 'Ospedale Clinicizzato Universitario SS. Annunziata', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'city': 'Ferrara', 'country': 'Italy', 'facility': "Arcispedale Sant'Anna", 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Azienda Ospedaliera San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Universita degli Studi di Genova', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Grassi', 'country': 'Italy', 'facility': 'Ospedale Luigi Sacco'}, {'city': 'Mestre', 'country': 'Italy', 'facility': 'Ospedale Civile Umberto I', 'geoPoint': {'lat': 45.49167, 'lon': 12.24538}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Montescano', 'country': 'Italy', 'facility': 'Istituto Scientifico di Riabilazione di Montescano', 'geoPoint': {'lat': 45.03196, 'lon': 9.28366}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Policlinico Universitario Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'UCADH', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Perugia', 'country': 'Italy', 'facility': 'Presidio Ospedaliero Monteluce', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Universita degli Studi di Roma', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Verona', 'country': 'Italy', 'facility': 'Policlinico G.B. Rossi', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Bialobrzeska', 'country': 'Poland', 'facility': 'Centrum Medyczne Osteomed'}, {'city': 'Elblag', 'country': 'Poland', 'facility': 'Centrum Kliniczno Badawcze', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Wojewodzki Szpiyal Spejalistyczny', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Center Of Clinical Neurology', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'Osrodek Baden Klinicznych', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Wojskowy Instytut Medyczny', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Wroclaw Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Zgierz', 'country': 'Poland', 'facility': 'Oddzial Neurologiczny', 'geoPoint': {'lat': 51.85561, 'lon': 19.40623}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Gartnavel General Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Barta and The London NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Solihull Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newron Pharmaceuticals SPA', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Stefano Rossetti, MD', 'oldOrganization': 'Newron Pharmaceuticals S.p.A'}}}}