Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-28 @ 6:06 PM
Study NCT ID:
NCT00635960
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2008-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth Hormone in Amyotrophic Lateral Sclerosis
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': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-25', 'studyFirstSubmitDate': '2008-03-03', 'studyFirstSubmitQcDate': '2008-03-13', 'lastUpdatePostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary endpoint is the N-acetylaspartate/Creatine ratio in the motor cortex assessed with magnetic resonance spectroscopy.', 'timeFrame': '0, 6 and 12 months after treatment start'}], 'secondaryOutcomes': [{'measure': 'Difference in mortality between groups', 'timeFrame': '12 months'}, {'measure': 'Difference in the ALS-FRS score (motor function scale)', 'timeFrame': '0, 6, and 12 months after treatment start'}, {'measure': 'Difference in the SF-36 score (quality of life )', 'timeFrame': '0, 6, and 12 monthst after treatmetn start'}, {'measure': 'Safety and tolerability', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Amyotrophic Lateral Sclerosis', 'ALS', 'Growth Hormone', 'IGF-I'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ibb.cnr.it/', 'label': 'Institute of Biostructure and Bioimaging, CNR Naples'}, {'url': 'http://www.unina.it', 'label': 'University "Federico II", Naples'}, {'url': 'http://www.policlinico.unina.it', 'label': 'Policlinico "Federico II", Naples'}, {'url': 'http://www.agenziafarmaco.it', 'label': 'AIFA'}]}, 'descriptionModule': {'briefSummary': 'Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine, creatine, Vit. E, Pentoxifylline, etc. Although most of the trials showed a positive trend, none of them reached a statistically significant result. The only exception is the Riluzole trial, that demonstrated a small but significant reduction in mortality between treated and untreated patients. Aim of our study is to determine if the add-on of GH to treatment with Riluzole is able to reduce neuronal loss in the motor cortex of ALS patients.', 'detailedDescription': 'Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine, creatine, Vit. E, Pentoxifylline. Although most of the trials showed a positive trend, none of them reached a statistically significant result. The only exception is the Riluzole trial, that demonstrated a small but significant reduction in mortality between treated and untreated patients. When administered to SOD-1 transgenic mice, IGF-I prolongs survival, ameliorates muscular strength, and reduces weight and motor neuron loss, astrocyte gliosis, and ubiquitin positive protein inclusions.\n\nTwo clinical trials have been performed in ALS patients with s.c. administration of IGF-I indicating a possible beneficial effect, and a third clinical trial is in progress. Methionyl growth hormone (mGH) showed no effect on survival, disease progression and muscular strength. MGH was administered at a fixed dose and peripheral production of IGF-I appeared to be normal. We propose a double-blind trial of Growth Hormone (GH) as add-on therapy to Riluzole, with an individually regulated dose based on the peripheral response of IGF-I. Aim of our study is to determine if the add-on of GH to treatment with Riluzole is able to reduce neuronal loss in the motor cortex of ALS patients. As secondary objectives, effect of GH on mortality, QoL, and motor function will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Definite/probable ALS according to El Escorial criteria\n* Aged \\> 40, \\< 85 years\n* Progression from onset\n* Disease duration ≤3 years\n* Treatment with Riluzole\n\nExclusion Criteria:\n\n* Rapid disease progression in the first 6 months after diagnosis\n* Patients with tracheostomy and/or Gastrostomy\n* Disease duration \\> 3 years\n* Patient with exclusive bulbar or 2° motorneuron involvement\n* Hepatic/renal failure\n* Pregnant or breastfeeding\n* Signs of active neoplasia\n* Complicated Diabetes\n* Severe hypertension\n* Unable to undergo MRI exams'}, 'identificationModule': {'nctId': 'NCT00635960', 'briefTitle': 'Growth Hormone in Amyotrophic Lateral Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Efficacy, Safety and Tolerability of Growth Hormone in Patients With Amyotrophic Lateral Sclerosis as add-on Therapy to Riluzole', 'orgStudyIdInfo': {'id': 'SLA_GH_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients randomly assigned to treatment', 'interventionNames': ['Drug: Growth Hormone (Somatropin)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Patients randomly assigned to placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Growth Hormone (Somatropin)', 'type': 'DRUG', 'otherNames': ['Saizen 8mg'], 'description': 'The initial dose will be 2U s.c. every other day. The dose will be progressively increased to reach 1.5-2x the normal levels of IGF-I.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saizen 8mg placebo'], 'description': 'Same as for Growth hormone group', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Diparimento di Scienze Neurologiche', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Istituto Biostrutture e Bioimmagini, Consiglio Nazionale delle Ricerche', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Alessandro Filla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University "Federico II", Naples'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Biostrutture e Immagini, CNR Naples', 'class': 'UNKNOWN'}, {'name': 'Agenzia Italiana del Farmaco', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Alessandro Filla, Prof.', 'oldOrganization': 'Dipartimento di Scienze Neurologiche, "Federico II" University, Naples'}}}}