Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-01-13 @ 3:44 AM
Study NCT ID:
NCT01825551
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2013-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of GCSF in the Treatment of ALS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-10', 'studyFirstSubmitDate': '2013-03-13', 'studyFirstSubmitQcDate': '2013-04-01', 'lastUpdatePostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "patient's function", 'timeFrame': 'one year', 'description': 'based on revised ALS Functional Rating scale (ALSFRS-r)'}], 'secondaryOutcomes': [{'measure': 'mobilizing bone marrow stem cells', 'timeFrame': '1 year', 'description': 'based on cluster of differentiation 34 (CD34) and white blood cell (WBC) counting'}, {'measure': 'amplitude of compound muscle action potential in ulnar and peroneal nerve', 'timeFrame': '1 year', 'description': 'based on compound muscle action potential (CMAP) measured in nerve conduction study'}, {'measure': 'quality of life', 'timeFrame': '1 year', 'description': 'based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40)'}, {'measure': 'muscle power', 'timeFrame': '1 year', 'description': 'based on Muscle Manual Test (MMT)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Amyotrophic Lateral Sclerosis', 'Granulocyte Colony Stimulating Factor'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 85\n* definite or probable ALS according to revised El Escorial criteria\n* maximum 2 years from initiation of symptoms to study entry\n* mild to moderate disability according to revised ALS functional rating scale (ALSFRS-r)\n\nExclusion Criteria:\n\n* familial ALS\n* pregnancy or lactation\n* myeloproliferative or hematologic disorders\n* active immunological disease\n* liver or renal or heart disease\n* HIV positive\n* significant cognitive disorder\n* hypersensitivity to GCSF'}, 'identificationModule': {'nctId': 'NCT01825551', 'briefTitle': 'The Effect of GCSF in the Treatment of ALS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'The Effect of Granulocyte Colony Stimulating Factor (GCSF) in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Patients Referred to Tehran Imam Khomeini and Shariati Hospital Centers in 2013', 'orgStudyIdInfo': {'id': '91-01-54-17265'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Granulocyte Colony Stimulating Factor', 'description': 'Granulocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously', 'interventionNames': ['Drug: Granulocyte Colony Stimulating Factor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'normal saline 0.01 ml/kg/day for 5 days subcutaneously', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Granulocyte Colony Stimulating Factor', 'type': 'DRUG', 'armGroupLabels': ['Granulocyte Colony Stimulating Factor']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Iranian Neurology Research Center of Tehran University of Medical Sciences', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}