Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT06639620
Status:
RECRUITING
Last Update Posted:
2025-08-25
First Post:
2024-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study To Assess Effectiveness and Adverse Events of Foscarbidopa/ Foslevodopa in Adult Participants With Advanced Parkinson Disease in Real Life Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-10-11', 'lastUpdatePostDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in Parkinson's Disease Questionnaire-8 (PDQ) total score.", 'timeFrame': 'Up to approximately 12 months', 'description': 'Parkinson Disease Questionnaire (PDQ)-8 is an eight-question instrument constructed by taking one question from each domain of PDQ-39: mobility, activities of daily of living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Each question is scored between 0 and 4 as follows: 0=Never and 4 = Always or cannot do at all. A higher score signifies poorer quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Parkinson disease', 'Foscarbidopa/ foslevodopa', 'ABBV-951', 'LDp/CDp'], 'conditions': ['Advanced Parkinson Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P24-820', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective foscarbidopa/ foslevodopa is in treating French adult participants with advanced Parkinson disease under routine clinical practice.\n\nFoslevodopa/foscarbidopa is an approved drug outside of US for the treatment of Parkinson's Disease. Approximately 200 adult participants who are prescribed foslevodopa/foscarbidopa by their doctors will be enrolled across approximately 30 sites in France.\n\nParticipants will receive foscarbidopa/ foslevodopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 months.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with advanced Parkinson disease treated with Foscarbidopa/ foslevodopa according to label in France', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with advanced Parkinson disease with motor complications insufficiently controlled by current therapy\n* Participants eligible for foscarbidopa / foslevodopa according to French label \\& regulation.\n* Treatment initiation decision prior to and independently from study enrolment\n\nExclusion Criteria:\n\n* Participants with any contraindication to foscarbidopa / foslevodopa.\n* Participants with Mini mental state examination (MMSE) score \\< 24'}, 'identificationModule': {'nctId': 'NCT06639620', 'acronym': 'ENVOL', 'briefTitle': 'Study To Assess Effectiveness and Adverse Events of Foscarbidopa/ Foslevodopa in Adult Participants With Advanced Parkinson Disease in Real Life Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Effectiveness aNd Use of fosleVOdopa-foscarbidopa in Advanced Parkinson Disease in Real Life Setting', 'orgStudyIdInfo': {'id': 'P24-820'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Foscarbidopa / Foslevodopa', 'description': 'Participants will receive foscarbidopa/ foslevodopa as prescribed by their physician according to local label'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67200', 'city': 'Strasbourg', 'state': 'Alsace', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 266843', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Gabriel-Montpied /ID# 267182', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '13885', 'city': 'Marseille', 'state': 'Bouches-du-Rhone', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hôpital La Timone /ID# 265932', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '22027', 'city': 'Saint-Brieuc', 'state': 'Brittany Region', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CH de Saint-Brieuc, Paimpol et Tréguier /ID# 266927', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '25000', 'city': 'Besançon', 'state': 'Doubs', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Besançon - Hôpital Jean Minjoz /ID# 266853', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '29200', 'city': 'Brest', 'state': 'Finistere', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Brest /ID# 266405', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '87042', 'city': 'Limoges', 'state': 'Franche-Comte', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu de Limoges /Id# 266043', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '68024', 'city': 'Colmar', 'state': 'Grand Est', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '03 89 12 41 55'}], 'facility': 'Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 266932', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '59037', 'city': 'Lille', 'state': 'Hauts-de-France', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro /ID# 265954', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34070', 'city': 'Montpellier', 'state': 'Herault', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Clinique Beausoleil /ID# 266920', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '35033', 'city': 'Rennes', 'state': 'Ille-et-Vilaine', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou /ID# 267665', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '56000', 'city': 'Vannes', 'state': 'Morbihan', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CH Bretagne Atlantique /ID# 268308', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}, {'zip': '31059', 'city': 'Toulouse', 'state': 'Occitanie', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu De Toulouse - Hopital Pierre Paul Ricquet /ID# 266031', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94010', 'city': 'Créteil', 'state': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 266034', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '84000', 'city': 'Avignon', 'state': "Provence-Alpes-Côte d'Azur Region", 'status': 'RECRUITING', 'country': 'France', 'facility': "Centre Hospitalier d'Avignon /ID# 266369", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '64109', 'city': 'Bayonne', 'state': 'Pyrenees-Atlantiques', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier de la Côte Basque /ID# 266846', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '69229', 'city': 'Lyon', 'state': 'Rhone', 'status': 'RECRUITING', 'country': 'France', 'facility': 'les Hospices Civils de Lyon (HCL) /ID# 266404', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '80000', 'city': 'Amiens', 'state': 'Somme', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Amiens-Picardie Site Sud /ID# 266039', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '83000', 'city': 'Toulon', 'state': 'Var', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal Toulon /ID# 266397', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '88021', 'city': 'Épinal', 'state': 'Vosges', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Emile Durkheim - Site Plateau de la Justice /ID# 267183', 'geoPoint': {'lat': 48.18324, 'lon': 6.45304}}, {'zip': '78000', 'city': 'Versailles', 'state': 'Yvelines', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Cabinet de Neurologie /ID# 268309', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}, {'zip': '62408', 'city': 'Béthune', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Ch Bethune - Beuvry /Id# 265994', 'geoPoint': {'lat': 50.52965, 'lon': 2.64003}}, {'zip': '19100', 'city': 'Brive-la-Gaillarde', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre hospitalier de Brive /ID# 265952', 'geoPoint': {'lat': 45.1589, 'lon': 1.53326}}, {'zip': '50102', 'city': 'Cherbourg', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Public du Cotentin - Hôpital Pasteur /ID# 265950', 'geoPoint': {'lat': 49.63984, 'lon': -1.61636}}, {'zip': '67500', 'city': 'Haguenau', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CH Haguenau /ID# 266029', 'geoPoint': {'lat': 48.81557, 'lon': 7.79051}}, {'zip': '54035', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHRU de NANCY /ID# 266385', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 266375', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75019', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hôpital Fondation Adolphe de Rothschild /ID# 266373', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76031', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU de Rouen /ID# 266390', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '44800', 'city': 'Saint-Herblain', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU de Nantes - Hopital Nord Laennec /ID# 266036', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '35403', 'city': 'St-Malo', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Centre Hospitalier de Saint Malo /ID# 265948', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'zip': '59300', 'city': 'Valenciennes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier de Valenciennes /ID# 266400', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}], 'centralContacts': [{'name': 'Sophie Carret Costin', 'role': 'CONTACT', 'email': 'sophie.carret@abbvie.com', 'phone': '+33 145 60 1498'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}