Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-26 @ 8:55 AM
Study NCT ID:
NCT02501395
Status:
COMPLETED
Last Update Posted:
2018-06-04
First Post:
2015-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI in Patients With Kennedy Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055534', 'term': 'Bulbo-Spinal Atrophy, X-Linked'}], 'ancestors': [{'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-01', 'studyFirstSubmitDate': '2015-07-14', 'studyFirstSubmitQcDate': '2015-07-15', 'lastUpdatePostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle fat fraction', 'timeFrame': 'One MRI scan per subject (exam lasts approximately 60 min.)', 'description': 'The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'One muscle strength test per subject (exam lasts approximately 60 min.)', 'description': 'Isokinetic muscle dynamometry will be used to measure muscle strength.'}, {'measure': 'Minimal dataset for data collection in Kennedy disease', 'timeFrame': 'Data will be collected once for patients with Kennedy disease (exam lasts approximately 90 min.)', 'description': "The 'minimal dataset for data collection in Kennedy disease' will be used to investigate the clinical spectrum of Kennedy disease."}]}, 'conditionsModule': {'conditions': ['Bulbo-Spinal Atrophy, X-Linked', 'Kennedy Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://neuromuscular.dk', 'label': 'The homepage of Copenhagen Neuromuscular Center, Denmark.'}]}, 'descriptionModule': {'briefSummary': 'Kennedy disease is an inherited neuromuscular disorder that is characterized by progressive muscle wasting and weakness. It typically starts with muscle spasms and tremors in the arms, followed by muscle weakness and atrophy of muscles in the arms and legs. The facial and bulbar muscles are also involved. However, the muscle involvement pattern has not been investigated systemically in Kennedy disease.\n\nThe primary aim of the study is to investigate the muscle involvement in patients with Kennedy disease using MRI. Secondary aims are to examine disease severity and to test MRI as a potential outcome measure for future clinical trials in Kennedy disease.\n\nApproximately 40 patients with Kennedy disease and 20 gender and age matched healthy voluntary controls will be recruited. The study consists of one visit per subject lasting 4-5 hours.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons in Denmark diagnosed with Kennedy disease is invited to the study.\n\nGender and age matched controls will be recruited to a control group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients with Kennedy disease:\n\nInclusion Criteria:\n\n* Confirmed Kennedy disease\n\nExclusion Criteria:\n\n* All contraindications for undergoing an MRI scan\n\nHealthy controls\n\nInclusion Criteria:\n\n* Fit age and gender criteria\n\nExclusion Criteria:\n\n* All contraindications for undergoing an MRI scan'}, 'identificationModule': {'nctId': 'NCT02501395', 'briefTitle': 'MRI in Patients With Kennedy Disease', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'MRI in Patients With Kennedy Disease', 'orgStudyIdInfo': {'id': 'H-15006316'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Kennedy disease', 'description': 'Men over 18 years old with confirmed Kennedy disease.', 'interventionNames': ['Other: No intervention, observational']}, {'label': 'Healthy, voluntary controls', 'description': 'Gender and age matched healthy, voluntary controls.', 'interventionNames': ['Other: No intervention, observational']}], 'interventions': [{'name': 'No intervention, observational', 'type': 'OTHER', 'armGroupLabels': ['Healthy, voluntary controls', 'Patients with Kennedy disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen Neuromuscular Center', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Julia R Dahlqvist, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, Copenhagen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Julia Dahlqvist, MD', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}