Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-03-08 @ 5:50 AM
Study NCT ID:
NCT00600093
Status:
TERMINATED
Last Update Posted:
2011-07-26
First Post:
2008-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine
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': 'D000547', 'term': 'Amantadine'}], 'ancestors': [{'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'whyStopped': 'PI leaving the institute for a fellowship.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-24', 'studyFirstSubmitDate': '2008-01-13', 'studyFirstSubmitQcDate': '2008-01-13', 'lastUpdatePostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA).', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'UPDRS score', 'timeFrame': '2,28 days'}, {'measure': 'Pain (vas score), Analgetic drugs requirement', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amantadine'], 'conditions': ['Parkinson Disease', 'Perioperative Care']}, 'referencesModule': {'references': [{'pmid': '24045608', 'type': 'DERIVED', 'citation': 'Raz A, Lev N, Orbach-Zinger S, Djaldetti R. Safety of perioperative treatment with intravenous amantadine in patients with Parkinson disease. Clin Neuropharmacol. 2013 Sep-Oct;36(5):166-9. doi: 10.1097/WNF.0b013e31829bd066.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether administrating of Amantadine (a dopamine agonist) to patients suffering from Parkinson disease during the perioperative period is safe, and to asses potential benefits of this treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with a diagnosis of Parkinson Disease refered for surgery at our institution.\n\nExclusion Criteria:\n\n* Cardiac and neurosurgical procedures\n* Inability to sign informed Consent\n* allergy to Amantadine\n* Congestive heart failure\n* Arrythmia (including bradycardia below 55 bpm)\n* renal failure (creatinin above 1.5)\n* If a patient will develop agitation or delirium lasting longer then 8 hours he will not receive the second dose of amantadine.'}, 'identificationModule': {'nctId': 'NCT00600093', 'briefTitle': 'Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine', 'orgStudyIdInfo': {'id': '4332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Amantadine']}], 'interventions': [{'name': 'Amantadine', 'type': 'DRUG', 'otherNames': ['PK MERZ'], 'description': 'IV Amantadine 200mg \\*1/d at the beginning of surgery and 24 hours following surgery', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Aeyal Raz, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Aeyal Raz, MD, PhD', 'oldOrganization': 'Rabin Medical Center'}}}}