Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
Study NCT ID:
NCT03929068
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2019-04-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-01', 'releaseDate': '2024-08-15'}, {'releaseDate': '2024-11-19', 'unreleaseDate': '2024-11-19'}, {'resetDate': '2025-01-10', 'releaseDate': '2024-11-25'}, {'resetDate': '2025-09-08', 'releaseDate': '2025-08-18'}], 'estimatedResultsFirstSubmitDate': '2024-08-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'C009265', 'term': 'carbidopa, levodopa drug combination'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-13', 'size': 448634, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-22T10:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Identified participants will be randomized to receive either placebo or carbidopa-levodopa for a period of three weeks before crossing over to the other arm of the study. The two periods will be separated by a one day washout period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-08', 'studyFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2019-04-24', 'lastUpdatePostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale - Change of spasticity severity from baseline with treatment and placebo', 'timeFrame': 'Weekly from screening to end of study (six weeks)', 'description': 'Numerical rating scale from 0-10, where 0 is no spasticity and 10 is worst possible spasticity'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale - Change of pain severity from baseline with treatment and placebo', 'timeFrame': 'Weekly from screening to end of study (six weeks)', 'description': 'Numerical rating scale from 0-10, where 0 is no pain and 10 is worst possible pain'}, {'measure': 'Visual Analog Scale - Change of muscle spasm severity from baseline with treatment and placebo', 'timeFrame': 'Weekly from screening to end of study (six weeks)', 'description': 'Numerical rating scale from 0-10, where 0 is no muscle spasm and 10 is worst possible muscle spasm'}, {'measure': 'Strength', 'timeFrame': 'At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)', 'description': 'Medical Research Council scale for muscle strength which grades power on a scale of 0 to 5 in relation to the maximum expected for that muscle, 0 being no movement observed to 5 being muscle contracts normally against full resistance.'}, {'measure': 'Spasticity', 'timeFrame': 'At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)', 'description': 'The Ashworth scale measures severity of spasticity on a scale of 1 to 5, where 1 is normal muscle tone and 5 is a rigid limb.'}, {'measure': 'Upper extremity function', 'timeFrame': 'At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)', 'description': '9-hole peg test'}, {'measure': 'Lower extremity function:10-meter Walk Test', 'timeFrame': 'At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)', 'description': '10-meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.'}, {'measure': 'Lower extremity function: Timed Up and Go (TUG) Test', 'timeFrame': 'At screening, at 3 weeks (following first arm), and at 6 weeks (following second arm)', 'description': "The TUG test measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down to asses a person's mobility and lower extremity function."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALS', 'PLS', 'Primary Lateral Sclerosis'], 'conditions': ['Amyotrophic Lateral Sclerosis', 'Motor Neuron Disease']}, 'descriptionModule': {'briefSummary': "Motivated by the success of dopaminergic drugs in treating rigidity associated with Parkinson's disease, some neurologists have used carbidopa-levodopa (Sinemet) to attempt to improve spasticity in ALS and PLS patients. However, data on the efficacy of carbidopa/levodopa is limited. Given the limited data and potential to improve the quality of life of these patients, the effectiveness of carbidopa-levodopa in ALS and PLS patients with severe spasticity should be studied. The investigators hypothesis is that administration of carbidopa-levodopa will improve spasticity in ALS and PLS patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ALS or PLS\n* Age greater than 18 years\n* Clinically significant spasticity.\n\nExclusion Criteria:\n\n* Individuals currently taking carbidopa-levodopa or with known hypersensitivity of any component of carbidopa-levodopa\n* Narrow-angle glaucoma\n* Current use of a non-selective monoamine oxidase inhibitor (MAOI)\n* History of malignant melanoma or suspicious skin lesions\n* History of depression, suicidal ideation, or psychosis\n* History of myocardial infarction, ventricular arrhythmia, or severe cardiopulmonary disease\n* Uncontrolled hypertension\n* Asthma\n* Renal disease\n* Hepatic disease\n* Endocrine disease\n* History of peptic ulcer\n* Pregnant and/or breastfeeding\n* Current participation in another interventional study'}, 'identificationModule': {'nctId': 'NCT03929068', 'acronym': 'ALS and PLS', 'briefTitle': 'Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Sinemet in ALS and PLS', 'orgStudyIdInfo': {'id': 'Sinemet-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'carbidopa-levodopa', 'description': 'Each tablet of carbidopa-levodopa in this study will be equivalent to half of a standard carbidopa-levodopa 25/100mg tablet. Participants will take one tablet three times a day for the first week of the study period, increasing to two tablets three times a day for the remainder of the study period.', 'interventionNames': ['Drug: carbidopa-levodopa']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will take one placebo tablet three times a day for the first week of the study period, increasing to two tablets three times a day for the remainder of the study period.', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'carbidopa-levodopa', 'type': 'DRUG', 'otherNames': ['Sinemet'], 'description': "Motivated by the success of dopaminergic drugs in treating rigidity associated with Parkinson's disease, some neurologists have used carbidopa-levodopa to attempt to improve spasticity in ALS and PLS patients.", 'armGroupLabels': ['carbidopa-levodopa']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Placebo will be given to maintain blinding of participants and study team.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Timothy M Miller, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-08-15', 'type': 'RELEASE'}, {'date': '2024-11-01', 'type': 'RESET'}, {'date': '2024-11-19', 'type': 'RELEASE'}, {'date': '2024-11-19', 'type': 'UNRELEASE'}, {'date': '2024-11-25', 'type': 'RELEASE'}, {'date': '2025-01-10', 'type': 'RESET'}, {'date': '2025-08-18', 'type': 'RELEASE'}, {'date': '2025-09-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Washington University School of Medicine'}}}}