Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT01725802
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2012-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007980', 'term': 'Levodopa'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2013-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2012-11-04', 'studyFirstSubmitQcDate': '2012-11-08', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and frequency of adverse events', 'timeFrame': 'up to 8 weeks', 'description': '1. Incidence and frequency of adverse events\n2. Adverse events reporting related to the ND0612 application, local safety score'}, {'measure': 'Withdrawal rate', 'timeFrame': '2 days', 'description': 'Withdrawal rates and discontinuations due to adverse events'}], 'secondaryOutcomes': [{'measure': 'LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC', 'timeFrame': 'Up to 2 days', 'description': 'LD PK profile after oral LD dosing administered with or without ND0612:'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': 'In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.', 'detailedDescription': 'Design: single center, double-blind, randomized, placebo-controlled, crossover study.\n\nStudy Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments.\n\nPopulation: Eight (8) PD subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n* Men and women with idiopathic Parkinson's disease\n* Subjects must experience motor fluctuations associated with LD/CD dosing\n* Modified Hoehn and Yahr stage \\< 5\n* Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy\n* Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.\n* Subjects must be age 30 or older.\n* Subjects must be willing and able to give informed consent.\n\nMain Exclusion Criteria:\n\n* Subjects with a clinically significant or unstable medical or surgical condition\n* Subjects with clinically significant psychiatric illness.\n* Pre-menopausal women, not using birth control method.\n* Subjects who have taken experimental medications within 60 days prior to baseline.\n* Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation)."}, 'identificationModule': {'nctId': 'NCT01725802', 'briefTitle': "A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients", 'organization': {'class': 'INDUSTRY', 'fullName': 'NeuroDerm Ltd.'}, 'officialTitle': 'A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients', 'orgStudyIdInfo': {'id': 'ND0612/002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment sequence A', 'description': 'Period 1. ND0612; Period 2. Placebo', 'interventionNames': ['Drug: Levodopa/carbidopa solution for SC administration', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence B', 'description': 'Period 1. Placebo; Period 2. ND0612', 'interventionNames': ['Drug: Levodopa/carbidopa solution for SC administration', 'Drug: Placebo']}], 'interventions': [{'name': 'Levodopa/carbidopa solution for SC administration', 'type': 'DRUG', 'otherNames': ['ND0612'], 'armGroupLabels': ['Treatment sequence A', 'Treatment sequence B']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline'], 'armGroupLabels': ['Treatment sequence A', 'Treatment sequence B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeuroDerm Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}