Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT00215904
Status:
COMPLETED
Last Update Posted:
2012-07-09
First Post:
2005-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
D-serine Adjuvant Treatment for Parkinson's Disease
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-05', 'studyFirstSubmitDate': '2005-09-18', 'studyFirstSubmitQcDate': '2005-09-18', 'lastUpdatePostDateStruct': {'date': '2012-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UPDRS scores', 'timeFrame': '6 weeks'}, {'measure': 'PANSS scores', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '21733283', 'type': 'DERIVED', 'citation': "Gelfin E, Kaufman Y, Korn-Lubetzki I, Bloch B, Kremer I, Javitt DC, Heresco-Levy U. D-serine adjuvant treatment alleviates behavioural and motor symptoms in Parkinson's disease. Int J Neuropsychopharmacol. 2012 May;15(4):543-9. doi: 10.1017/S1461145711001015. Epub 2011 Jul 7."}]}, 'descriptionModule': {'briefSummary': "The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine (\\~2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced dyskinesias.\n\nD-serine will be used as add-on therapy to on-going medications received by Parkinson's Disease patients. The rational for this study stems from observations made in pervious clinical trials with schizophrenia patients, in which it was demonstrated that D-serine adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's Disease.\n\nThe study will have a crossover design in accordance to which each patient will receive, in random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have the opportunity to receive the experimental treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PD diagnosis\n* ≥2 on UPDRS items 32,33\n* receive treatment with L-dopa alone or in combination with other antiparkinsonian medications.\n\nExclusion Criteria:\n\n* current or previous history of other neurological disorders\n* unstable medical conditions\n* renal pathology\n* pregnant female patients excluded'}, 'identificationModule': {'nctId': 'NCT00215904', 'briefTitle': "D-serine Adjuvant Treatment for Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Herzog Hospital'}, 'officialTitle': "D-serine Adjuvant Treatment for Parkinson's Disease", 'orgStudyIdInfo': {'id': 'Heresco1CTIL'}, 'secondaryIdInfos': [{'id': '20030312'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: D-serine (~2g/day)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: D-serine (~2g/day)']}], 'interventions': [{'name': 'D-serine (~2g/day)', 'type': 'DRUG', 'description': 'Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (\\~2g/day). Second arm : adjuvant treatment with placebo (\\~2g/day).', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91351', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Ezrath Nashim - Herzog Memorial Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Uriel Heresco-Levy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ezrath Nashim - Herzog Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herzog Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Princepal Investigator', 'investigatorFullName': 'Heresco-Levi Uriel', 'investigatorAffiliation': 'Herzog Hospital'}}}}