Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-01-01 @ 4:28 AM
Study NCT ID:
NCT00752934
Status:
TERMINATED
Last Update Posted:
2018-12-31
First Post:
2008-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D011782', 'term': 'Quadriplegia'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001418', 'term': 'Baclofen'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-27', 'studyFirstSubmitDate': '2008-09-15', 'studyFirstSubmitQcDate': '2008-09-15', 'lastUpdatePostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'care and comport questionnaires', 'timeFrame': '28 weeks'}]}, 'conditionsModule': {'keywords': ['nursing homes', 'children', 'ages 1-18 years', 'spastic quadriplegia'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Baclofen is a drug that reduces the muscle stiffness. In disabled children that have very stiff muscles, the stiffness and secondary changes in the joints may cause discomfort and pain. In this study we will check if treatment with Baclofen reduces pain in disabled children with stiff muscles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cerebral palsy nursing homes children ages 1-18 years spastic quadriplegia\n\nExclusion Criteria:\n\n* active epilepsy severe truncal hypotonia'}, 'identificationModule': {'nctId': 'NCT00752934', 'briefTitle': 'Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'orgStudyIdInfo': {'id': '59/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group a', 'description': 'Baclofen followed by Placebo', 'interventionNames': ['Drug: oral baclofen + placebo']}, {'type': 'EXPERIMENTAL', 'label': 'group b', 'description': 'Placebo followed by Baclofen', 'interventionNames': ['Drug: placebo + oral baclofen']}], 'interventions': [{'name': 'oral baclofen + placebo', 'type': 'DRUG', 'description': "Group A will be given 13 weeks of oral baclofen followed by a 2-week non-treatment (washout) period, and then 13 weeks of oral placebo.\n\nFor participants who with weight under 15 Kg at the time of enrolment, the initial oral baclofen dose will be 2.5 mg daily, increasing weekly over a 7-week period to 10 mg three times a day, and will be continued at that dose for the following 5 weeks.\n\nFor those participants who will be over 15 Kg at the time of enrollment, the starting oral baclofen dose will be 5 mg daily, increasing over a 9-week period to 20 mg three times a day, and will be continued for the next 3 weeks at that dose. At the end of each 12-week period, the drug (either baclofen or placebo) will be tapered over 6 days.\n\nChildren's carers will given information on possible side effects, and asked to contact one of the researchers if any adverse events occur.", 'armGroupLabels': ['group a']}, {'name': 'placebo + oral baclofen', 'type': 'DRUG', 'description': 'Group B will receive 13 weeks of oral placebo followed by 2-week nontreatment, and then 13 weeks of oral baclofen', 'armGroupLabels': ['group b']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Saare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Dr. Hilla Ben-Pazi', 'investigatorAffiliation': 'Shaare Zedek Medical Center'}}}}