Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT00998634
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2009-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Lithium in Spinocerebellar Ataxia 2 (SCA2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020754', 'term': 'Spinocerebellar Ataxias'}], 'ancestors': [{'id': 'D002524', 'term': 'Cerebellar Ataxia'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016651', 'term': 'Lithium Carbonate'}], 'ancestors': [{'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D018020', 'term': 'Lithium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-07', 'studyFirstSubmitDate': '2009-10-16', 'studyFirstSubmitQcDate': '2009-10-19', 'lastUpdatePostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary endpoint of the study will be the difference in the number and frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) recorded during the study, between treatment and placebo group.', 'timeFrame': 'the endpoint will be recorded at all visits', 'description': 'Adverse events and Severe Adverse events will be recorded during the trial at each visit starting from Baseline to Visit 8 at 48 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome will be the Scale for the Assessment and Rating of Ataxia (SARA). Statistical analysis will be performed to compare the effect of treatment on both groups.', 'timeFrame': '0 weeks'}, {'measure': 'Micro- and macrostructural Magnetic Resonance parameters will be compared before and after treatment. This will include Voxel Based Morphometry, resting functional MRI, Diffusion tensor imaging and MRI spectroscopy.', 'timeFrame': '0 weeks'}, {'measure': 'The effect of Lithium on mood will be explored with the Beck depression inventory.', 'timeFrame': '0 weeks'}, {'measure': 'Effect of Lithium on quality of life will be assessed with the EQ-5D scale.', 'timeFrame': '0 weeks'}, {'measure': 'Secondary outcome will be the Scale for the Assessment and Rating of Ataxia (SARA). Statistical analysis will be performed to compare the effect of treatment on both groups.', 'timeFrame': '24 weeks'}, {'measure': 'Secondary outcome will be the Scale for the Assessment and Rating of Ataxia (SARA). Statistical analysis will be performed to compare the effect of treatment on both groups.', 'timeFrame': '48 weeks'}, {'measure': 'Micro- and macrostructural Magnetic Resonance parameters will be compared before and after treatment. This will include Voxel Based Morphometry, resting functional MRI, Diffusion tensor imaging and MRI spectroscopy.', 'timeFrame': '48 weeks'}, {'measure': 'The effect of Lithium on mood will be explored with the Beck depression inventory.', 'timeFrame': '24 weeks'}, {'measure': 'The effect of Lithium on mood will be explored with the Beck depression inventory.', 'timeFrame': '48 weeks'}, {'measure': 'Effect of Lithium on quality of life will be assessed with the EQ-5D scale.', 'timeFrame': '24 weeks'}, {'measure': 'Effect of Lithium on quality of life will be assessed with the EQ-5D scale.', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SCA2', 'Lithium'], 'conditions': ['SPINOCEREBELLAR ATAXIA 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.unina.it', 'label': 'University Federico II'}, {'url': 'http://www.policlinico.unina.it', 'label': 'AOU Policlinico "Federico II"'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine safety and tolerability of the treatment with lithium in Spinocerebellar Ataxia 2. Moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.', 'detailedDescription': 'Patients will be progressively enrolled in the study and undergo a screening visit to test for inclusion/exclusion criteria. Patients will then be randomized to receive either Lithium carbonate or placebo. Patients will visit study center at 2, 4, 8, 12, 24, 36 and 48 weeks, for endpoint and laboratory assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Molecular diagnosis of SCA2 (≥34 CAG in the ataxin-2 gene)\n* Age ≥18, \\<80\n* SARA score ≥8\n\nExclusion Criteria:\n\n* SARA score \\>32\n* Heart failure\n* Liver disease\n* Kidney failure\n* Thyroid disease\n* Sick sinus syndrome and/or significant ECG alterations\n* Hyposodemia\n* Treatment with diuretics\n* Treatment with haloperidol and/or other antipsychotics\n* Treatment with NSAIDs or corticosteroids\n* Treatment with ACE inhibitors\n* Treatment with aminophyllines\n* Treatment with mannitol\n* Pregnancy and/or breastfeeding\n* Acute diseases that might interfere with the trial'}, 'identificationModule': {'nctId': 'NCT00998634', 'acronym': 'LISCA2', 'briefTitle': 'Safety and Tolerability of Lithium in Spinocerebellar Ataxia 2 (SCA2)', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Randomized, Placebo-controlled Trial to Test Safety, Tolerability and Efficacy of Lithium Carbonate in Spinocerebellar Ataxia 2', 'orgStudyIdInfo': {'id': 'SCA_LITIO_12'}, 'secondaryIdInfos': [{'id': 'EUDRACT N°2009-016317-20'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LITHIUM CARBONATE 150 and/or 300 mg', 'interventionNames': ['Drug: LITHIUM CARBONATE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'interventionNames': ['Drug: LITHIUM CARBONATE']}], 'interventions': [{'name': 'LITHIUM CARBONATE', 'type': 'DRUG', 'description': 'Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.', 'armGroupLabels': ['LITHIUM CARBONATE 150 and/or 300 mg', 'PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Dipartimento di Scienze Neurologiche', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'overallOfficials': [{'name': 'Alessandro Filla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Federico II'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alessandro Filla', 'investigatorAffiliation': 'Federico II University'}}}}