Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-27 @ 7:41 AM
Study NCT ID:
NCT01421992
Status:
COMPLETED
Last Update Posted:
2011-08-23
First Post:
2011-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methylphenidate in Myotonic Dystrophy Type 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009223', 'term': 'Myotonic Dystrophy'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020967', 'term': 'Myotonic Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-22', 'studyFirstSubmitDate': '2011-06-01', 'studyFirstSubmitQcDate': '2011-08-22', 'lastUpdatePostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of excessive daytime sleepiness', 'timeFrame': '3 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of POMS, Rand36-Item Health survey and mean sleep latency', 'timeFrame': '3 weeks after treatment', 'description': "Mean sleep latency was measured using the behavioural Osler's test"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['randomized', 'double-blind', 'crossover', 'methylphenidate', 'excessive daytime sleepiness'], 'conditions': ['Dystrophia Myotonica 1']}, 'referencesModule': {'references': [{'pmid': '39555632', 'type': 'DERIVED', 'citation': 'Annane D, Laberge L, Gallais B, Chevret S. Psychostimulants for hypersomnia (excessive daytime sleepiness) in myotonic dystrophy. Cochrane Database Syst Rev. 2024 Nov 18;11(11):CD003218. doi: 10.1002/14651858.CD003218.pub3.'}, {'pmid': '22578232', 'type': 'DERIVED', 'citation': 'Puymirat J, Bouchard JP, Mathieu J. Efficacy and tolerability of a 20-mg dose of methylphenidate for the treatment of daytime sleepiness in adult patients with myotonic dystrophy type 1: a 2-center, randomized, double-blind, placebo-controlled, 3-week crossover trial. Clin Ther. 2012 May;34(5):1103-11. doi: 10.1016/j.clinthera.2012.03.060.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether methylphenidate is effective in the treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1).', 'detailedDescription': 'Myotonic dystrophy type 1 (DM1) is a multisystemic disorder characterized by muscle weakness, myotonia, and the involvement of several systems. Hypersomnolence is one of the most frequently reported symptoms in patients with DM1 and often lead to handicap such as cessation of employment and withdrawal from social activities.The current investigation represents a prospective, double-blind, randomized, crossover, placebo-controlled study designed to evaluate the efficacy of methylphenidate for the treatment of excessive daytime sleepiness (EDS) in adults with DM1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults\n* Epworth score ≥ 10\n* Diagnosis of myotonic dystrophy type 1\n\nExclusion Criteria:\n\n* hypersensibility to methylphenidate\n* Pregnancy\n* Patients who receive drugs that interfere with methylphenidate\n* Cognitive impairment\n* Sleep apnea'}, 'identificationModule': {'nctId': 'NCT01421992', 'briefTitle': 'Methylphenidate in Myotonic Dystrophy Type 1', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Phase 2/3 Study of Efficacy and Tolerability of Methylphenidate in the Treatment of Excessive Daytime Sleepiness in Myotonic Dystrophy Type 1', 'orgStudyIdInfo': {'id': 'AFM-12117'}, 'secondaryIdInfos': [{'id': 'AFM-12117', 'type': 'OTHER_GRANT', 'domain': 'AFM-12117'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1: Methylphenidate versus baseline', 'interventionNames': ['Drug: Methylphenidate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2: Placebo versus baseline', 'description': 'One table placebo per day during 3 week', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Methylphenidate', 'type': 'DRUG', 'otherNames': ['Ritalin'], 'description': 'One Tablet of methylphenidate, 20 mg per day during 3 weeks', 'armGroupLabels': ['Arm 1: Methylphenidate versus baseline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'one tablet placebo per day during 3 weeks', 'armGroupLabels': ['Arm 2: Placebo versus baseline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1M2S8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institute of Readaptation in Physical Deficiency', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Jack J Puymirat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Laval'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}