Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-31 @ 2:58 PM
Study NCT ID:
NCT02143167
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2014-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Training and Amino Pyridine in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015761', 'term': '4-Aminopyridine'}], 'ancestors': [{'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2014-05-09', 'studyFirstSubmitQcDate': '2014-05-16', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle power in the lower limbs', 'timeFrame': 'Muscle power will be measured after 14 weeks of resistance training.', 'description': 'Muscle power in the lower limbs is measured by dynamometry pre and post resistance training'}], 'secondaryOutcomes': [{'measure': 'Activity', 'timeFrame': 'Accelerometry is measured after 14 weeks of resistance training', 'description': 'Activity measured by accelerometry.'}, {'measure': 'Walking capacity', 'timeFrame': 'Walking capacity is measured after 26 weeks of resistance training', 'description': 'Walking capacity measured by the Six Spot Step Test (SSST)'}, {'measure': 'Walking speed', 'timeFrame': 'Walking speed is measured after 26 weeks of resistance training', 'description': 'Walking speed measured by the Timed 25 Foot Walk (T25FW) and the 6-Minute Walking Test (6MWT)'}, {'measure': 'Functional capacity in the lower limbs', 'timeFrame': 'Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training', 'description': 'Functional capacity measured by the Chair Stand Test (CST)'}, {'measure': 'Self rated walking capacity', 'timeFrame': 'Self rated walking capacity is measured after 26 weeks of resistance training', 'description': 'Self rated walking capacity measured by the 12-Item Multiple Sclerosis Walking Scale (MSWS12)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '19884575', 'type': 'BACKGROUND', 'citation': 'Dalgas U, Stenager E, Jakobsen J, Petersen T, Hansen HJ, Knudsen C, Overgaard K, Ingemann-Hansen T. Resistance training improves muscle strength and functional capacity in multiple sclerosis. Neurology. 2009 Nov 3;73(18):1478-84. doi: 10.1212/WNL.0b013e3181bf98b4.'}, {'pmid': '20976768', 'type': 'BACKGROUND', 'citation': 'Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.'}, {'pmid': '19249634', 'type': 'BACKGROUND', 'citation': 'Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.'}]}, 'descriptionModule': {'briefSummary': 'Prolonged-release fampridine (SR-fampridine) can improving walking capacity in approximately 40% of MS patients suffering from this by overcoming partly or total conduction block due to demyelination.\n\nResistance training has been shown to provide the same kind of benefits for patients by targeting the muscular component of the motor unit. Thus by combining the two it is likely to see an synergistic effect.\n\nThis trial is designed as a double blind, randomized placebo controlled trial with subsequent cross-over.\n\nParticipants in the two arms will go through the same progressive training program targets at the lower limbs. For 24 weeks one group receives SR-fampridine and the other receives placebo. in the the end there is another four weeks of training after cross-over has been performed.', 'detailedDescription': 'See above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) fulfilling the McDonald criteria\n* Expandend Disability Status Scale (EDSS) 3-6.5\n* Pyramidal Functional Score ≥ 2\n* Participants must be able to transport self to gym and to the University of Southern Denmark\n* Participants must be able to complete T25FW and SSST\n* Fertile female participants are obliged to use hormonal contraceptive measures\n\nExclusion Criteria:\n\n* History of epileptic seizures\n* MS relapse or change in disease modifying treatment (DMT) within 60 days\n* Cancer within five years\n* Blood pressure ≥ 160/100\n* Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation\n* ≥ ALT 90 U/l, ≥ BSP 210 U/l, ≥ γ-GT 230 U/l\n* GFR \\< 80 ml/min.\n* History of severe pulmonary disease or unexplained abnormal pulmonary auscultation\n* Pregnancy\n* Breastfeeding\n* Allergy to substances contained in prolonged release Fampridine tablets\n* Concomitant treatment with carvedilol, propranolol or metformin.'}, 'identificationModule': {'nctId': 'NCT02143167', 'acronym': 'RETRAP', 'briefTitle': 'Resistance Training and Amino Pyridine in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'RETRAP - A Double Blind, Randomized, Placebo Controlled Study of the Effect of the Combination of Resistance Training and Prolonged Release Fampridine in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'RETRAP'}, 'secondaryIdInfos': [{'id': '2011-002959-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SR-fampridine/placebo', 'description': '24 weeks of SR-fampridine followed by four weeks of inactive placebo.', 'interventionNames': ['Drug: SR-fampridine', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo/SR-fampridine', 'description': '24 weeks of inactive placebo followed by four weeks of SR-fampridine', 'interventionNames': ['Drug: SR-fampridine', 'Drug: Placebo']}], 'interventions': [{'name': 'SR-fampridine', 'type': 'DRUG', 'otherNames': ['Fampyra'], 'description': 'One arm receives SR-fampridine 10 mg BID for 24 weeks followed by four weeks of inactive placebo BID.\n\nThe other arm receives placebo BID for 24 weeks followed by four weeks of SR-fampridine 10 mg BID for four weeks.', 'armGroupLabels': ['Placebo/SR-fampridine', 'SR-fampridine/placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo/SR-fampridine', 'SR-fampridine/placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Sydvestjysk Sygehus', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '6400', 'city': 'Sønderborg', 'country': 'Denmark', 'facility': 'Sygehus Sønderjylland', 'geoPoint': {'lat': 54.90896, 'lon': 9.78917}}, {'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Sygehus Lillebælt', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Henrik B Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region of Southern Denmark', 'class': 'OTHER'}, {'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Henrik Boye Jensen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}