Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00959218
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2009-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to 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': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-02', 'studyFirstSubmitDate': '2009-08-13', 'studyFirstSubmitQcDate': '2009-08-13', 'lastUpdatePostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary', 'timeFrame': 'max. 2.5 years'}], 'secondaryOutcomes': [{'measure': 'Likert Numerical Rating Scale pain relief', 'timeFrame': 'max. 2.5 years'}, {'measure': 'Pain-related sleep interference', 'timeFrame': 'max. 2.5 years'}, {'measure': 'SF-36 (QoL-questionnaire)', 'timeFrame': 'max. 2.5 years'}, {'measure': 'Intake of rescue medication', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dronabinol', '(-)trans-delta9-tetrahydrocannabinol', 'central neuropathic pain', 'multiple sclerosis', 'analgesic', 'Central neuropathic pain related to multiple sclerosis'], 'conditions': ['Central Neuropathic Pain in Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.', 'detailedDescription': "Multiple sclerosis (MS) is in all probability an autoimmune disease causing severe neurological disability due to inflammation and degeneration in the central nervous system (CNS). MS affects over 1 million people worldwide. Central neuropathic pain is associated with approximately 30% of all patients with MS. MS-accompanying pain has a major impact on the patients' quality of life as usual conventional analgesics are little effective. The aim of this clinical study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of multiple sclerosis acc. to McDonald diagnostic criteria\n* EDSS score between 3 and 8 (incl.)\n* Patients who are in a stable phase of multiple sclerosis\n* Patients with MS-related central neuropathic pain for at least 3 months\n\nExclusion Criteria:\n\n* Severe concomitant diseases\n* Certain concomitant therapies (in particular: pain influencing concomitant therapies)\n* Dronabinol intake within the last 12 months prior to study entry or Marihuana use within one month prior to study entry'}, 'identificationModule': {'nctId': 'NCT00959218', 'briefTitle': 'Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bionorica Research GmbH'}, 'officialTitle': 'Multi-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic Pain', 'orgStudyIdInfo': {'id': 'cnp-MS-0601 / MC-2006-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dronabinol', 'interventionNames': ['Drug: Dronabinol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dronabinol', 'type': 'DRUG', 'otherNames': ['(-)trans-delta9-tetrahydrocannabinol'], 'description': 'oral solution, daily dose up to 15 mg, treatment up to 2.5 years', 'armGroupLabels': ['Dronabinol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58515', 'city': 'Lüdenscheid', 'country': 'Germany', 'facility': 'Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie', 'geoPoint': {'lat': 51.21977, 'lon': 7.6273}}], 'overallOfficials': [{'name': 'Sebastian Schimrigk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Luedenscheid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bionorica Research GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}