Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT00286260
Status:
COMPLETED
Last Update Posted:
2009-12-18
First Post:
2006-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Levetiracetam for Painful Polyneuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-17', 'studyFirstSubmitDate': '2006-02-01', 'studyFirstSubmitQcDate': '2006-02-01', 'lastUpdatePostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period)', 'timeFrame': 'Daily'}], 'secondaryOutcomes': [{'measure': 'Pain rated on 0 to 10 point numeric rating scales', 'timeFrame': 'Daily'}, {'measure': 'Pain subtypes rated on 0 to 10 point numeric rating scales', 'timeFrame': 'Daily'}, {'measure': 'Bruch-evoked pain', 'timeFrame': 'Baseline and end of each treament period'}, {'measure': 'Pin-prick evoked pain', 'timeFrame': 'Baseline and end of each treatment period'}, {'measure': 'Cold evoked pain', 'timeFrame': 'Baseline and end of each treatment period'}, {'measure': 'Health related quality of life(SF-36)', 'timeFrame': 'Baseline and end of each treatment period'}, {'measure': 'Pain related sleep disturbance', 'timeFrame': 'Daily'}, {'measure': 'Use of escape medication', 'timeFrame': 'Daily'}]}, 'conditionsModule': {'keywords': ['polyneuropathy', 'neuropathic pain', 'levetiracetam'], 'conditions': ['Painful Polyneuropathy']}, 'descriptionModule': {'briefSummary': 'Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20 to 0 years\n* painful symptoms of polyneuropathy for at least 6 months\n* confirmed diagnosis of polyneuropathy\n* baseline pain score of 4 or more (0 to 10 point scale)\n* pain at least 4 days a week\n* adequate anticonceptive treatment for women with childbearing potential\n* informed consent\n\nExclusion Criteria:\n\n* other cause of pain\n* previous allergic reactions towards levetiracetam\n* known adverse drug reactions on levetiracetam\n* pregnancy\n* severe disease\n* inability to follow study protocol\n* treatment with antidepressants, other anticonvulsants or opioids'}, 'identificationModule': {'nctId': 'NCT00286260', 'briefTitle': 'Levetiracetam for Painful Polyneuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy', 'orgStudyIdInfo': {'id': 'keppra2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'levetiracetam', 'type': 'DRUG', 'description': 'Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-5000', 'city': 'Odense C', 'country': 'Denmark', 'facility': 'Department of Neurology, Odense University Hospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}], 'overallOfficials': [{'name': 'Søren H Sindrup, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Neurology, Odense Unviersity Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Søren H. Sindrup', 'oldOrganization': 'Odense University Hospital'}}}}