Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT00220493
Status:
UNKNOWN
Last Update Posted:
2007-01-05
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'ECT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2005-06'}, 'lastUpdateSubmitDate': '2007-01-04', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2007-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo'}]}, 'conditionsModule': {'keywords': ['MS', 'RITALIN', 'PASAT', 'COGNITION', 'ATTENTION', 'Relapsing remitting', 'Secondary progressive', 'Primary progressive'], 'conditions': ['Relapsing Remitting Multiple Sclerosis', 'Multiple Sclerosis, Chronic Progressive']}, 'descriptionModule': {'briefSummary': 'Scientific background:\n\nGrowing awareness and accumulating data regarding the cognitive impairment and its progression in multiple sclerosis (MS) patients has received an important place in neurological research in the last decade.', 'detailedDescription': 'Scientific background:\n\nGrowing awareness and accumulating data regarding the cognitive impairment and its progression in multiple sclerosis (MS) patients has received an important place in neurological research in the last decade. Cognitive impairments occur frequently (43 to 65%) in MS. Moreover, in up to 50% of patients in whom no cognitive disturbances are found on routine neurological examination, cognitive impairments can be elicited using sensitive and disease specific neuropsychological tests. Even in patients with short disease duration of less than two years, discrete impairment of cognitive function may be found in up to 60% on neuropsychological testing without impacting activities of daily living.\n\nWe have recently reported that cognitive impairment occurred in 53.7% of patients with probable MS (evaluated within a mean of one month of the onset of new neurological symptoms). Verbal abilities and attention span were most frequently affected (43.3 and 41.8% respectively). An additional study demonstrated that MS patients within the first 5 years of disease onset presented attentional dysfunction only when the cognitive load of the attention task was high and when controlled information processing was required. This high rate of attention impairment found in MS patients early in the disease process may have a significant impact on quality of life and activities of daily living as attention is one of the most fundamental cognitive functions essential for normal daily activities and a requisite step towards conscious perception. Consequently, we suggest investigating whether treatment with Ritalin (methylphenidate) has an effect on patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of definite MS according to Poser criteria;\n* Attention impairment defined as abnormal PASAT score;\n* Written and signed informed consent;\n\nExclusion Criteria:\n\n* Pregnancy or lactation;\n* Steroid treatment;\n* Persistent psychostimulant treatment;\n* MS relapse;'}, 'identificationModule': {'nctId': 'NCT00220493', 'briefTitle': 'Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Clinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis Patients', 'orgStudyIdInfo': {'id': 'SHEBA-03-2966-AA-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ritalin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Anat Achiron, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Multiple Sclerosis Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Anat Achiron, MD PhD', 'role': 'CONTACT', 'email': 'ACHIRON@POST.TAU.AC.IL', 'phone': '972-3-5303932'}, {'name': 'Nava Appleboim-Gavish, MA', 'role': 'CONTACT', 'email': 'nava_a@hotmail.com', 'phone': '972-3-5305309'}], 'overallOfficials': [{'name': 'Anat Achiron, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sackler School of Medicine'}, {'name': 'Yirmiyahu Harel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sachler School of Medicine'}, {'name': 'Nava Appleboim-Gavish, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center at Tel Hashomer Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}}}}