Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-27 @ 9:05 AM
Study NCT ID:
NCT01329757
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2011-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-27', 'studyFirstSubmitDate': '2011-04-04', 'studyFirstSubmitQcDate': '2011-04-05', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Score of the American Spinal Injury Association (ASIA) scale', 'timeFrame': '12 months', 'description': 'Motor score of the ASIA scale reports the strenght of 10 key muscles in each body side (5 key muscles in upper limb and 5 key muscles in lower limb). The strenght is rated between 0 and 5 (Medical Research Council-MRC scale). The ASIA motor score range is between 0 and 100 (normal).'}], 'secondaryOutcomes': [{'measure': 'ASIA', 'timeFrame': '12 months', 'description': 'ASIA grades'}, {'measure': 'ASIA sensory score', 'timeFrame': '12 months', 'description': 'ASIA sensory score'}, {'measure': 'Spasticity', 'timeFrame': 'Baseline, 15 days, 6 months, 12 months', 'description': 'Penn scale and Ashworth scale'}, {'measure': 'Pain', 'timeFrame': 'Baseline, 15 days, 6 months, 12 months', 'description': 'Visual analogic scale (VAS)'}, {'measure': 'Independence Measures and Quality of life', 'timeFrame': '12 months', 'description': 'Spinal Cord Indipendence Measures (SCIM) and the Quality of Life Questionnaire (EQ 5D)'}, {'measure': 'Neurophysiological Measures', 'timeFrame': '6 months and 12 months', 'description': 'Motor Evoked Potentials, Somatosensory Evoked Potentials, Motor Neurography'}, {'measure': 'Safety', 'timeFrame': '15, 30, 60, 90, 120, 150, 180, 360 days', 'description': 'Recording of any adverse event, full blood and urine examination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spinal Cord Injury', 'Growth Hormone', 'Trauma', 'Incomplete', 'ASIA'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'Objectives: To evaluate the efficacy and safety of one year treatment based on daily doses of exogenous growth hormone (GH) in patients with traumatic spinal cord injury. The first six months the pharmacological treatment will be associated to rehabilitation treatment.\n\nThe main hypothesis is that GH can improve motor function of patients with traumatic spinal cord injury below the lesion level. The hypothesis is based on possible effects of GH at muscle and synaptic level. GH can also promote axonal growth and regeneration.\n\nDesign: Clinical trial placebo-controlled, double-blind intervention with blind evaluation by third parties and blinding in the analysis of data (triple-blind design).\n\nDuration of intervention and monitoring: 364 days.\n\nPrimary outcome measures. Changes of the American Spinal Injury Association (ASIA) scale (motor score)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Traumatic Spinal cord injury\n* Incomplete (ASIA scale B or C)\n* Level of injury: Between C4 and D12\n* More than 18 months from the SCI injury.\n\nExclusion Criteria:\n\n* Non traumatic Spinal cord injury\n* Complete SCI (ASIA A)\n* Incomplete (ASIA D or E)\n* Less than 18 months from the SCI\n* Intensive Care Unit (ICU) staying for a period of 2 months or more\n* More than 3 urological infections in the last year\n* Pneumonia in the 6 months prior to the study\n* Severe respiratory failure\n* History of head trauma\n* Severe psychiatric disorder\n* A history of heart disease, diabetes or hypertension\n* Concomitant Neurological Diseases\n* Regular use of substances of abuse\n* Patients with severe kidney and / or liver failure.\n* Patients who can not be included in an intensive rehabilitation program\n* Patients who are pregnant or breast-feeding\n* History of malignancy\n* Impossibility to obtain informed consent'}, 'identificationModule': {'nctId': 'NCT01329757', 'acronym': 'GHSCI', 'briefTitle': 'Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Nacional de Parapléjicos de Toledo'}, 'officialTitle': 'Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'FHNP-CT001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GH', 'description': 'Administration of a daily dose of GH (0.4mg)for 1 year', 'interventionNames': ['Drug: GH']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administration of a daily dose of placebo for 1 year', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GH', 'type': 'DRUG', 'otherNames': ['Genotonorm'], 'description': 'Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year', 'armGroupLabels': ['GH']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Provided by the Genotonorm producer (Pfizer)'], 'description': 'Administration of a subcutaneously injected daily dose of placebo for 1 year', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45004', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Nacional de Paraplejicos', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'overallOfficials': [{'name': 'Antonio Oliviero, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Nacional de Paraplejicos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Nacional de Parapléjicos de Toledo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministerio de Salud y Politicas Sociales (Ministry of Health)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Neurologist', 'investigatorFullName': 'Antonio Oliviero', 'investigatorAffiliation': 'Hospital Nacional de Parapléjicos de Toledo'}}}}