Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-27 @ 7:43 PM
Study NCT ID:
NCT01222468
Status:
COMPLETED
Last Update Posted:
2015-02-25
First Post:
2010-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C011941', 'term': 'nabilone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-24', 'studyFirstSubmitDate': '2010-10-14', 'studyFirstSubmitQcDate': '2010-10-15', 'lastUpdatePostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ashworth Scale', 'timeFrame': '26 weeks', 'description': 'A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4.'}, {'measure': 'VAS (visual analog scale)pain intensity scale', 'timeFrame': '26 weeks', 'description': 'Primary outcome measure for pain will be a change in the VAS pain intensity scale. Using a visual intensity scale, patients are asked to record their daily pain score over the previous 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Sum of the Ashworth Scale in the eight muscle groups of each side of the body.', 'timeFrame': '26 weeks', 'description': 'As above'}, {'measure': 'Penn Spasm Frequency Scale', 'timeFrame': '26 weeks', 'description': 'Scale graded by study participants to measure frequency of muscle spasms throughout the period in question'}, {'measure': 'Visual Analog Scale', 'timeFrame': '26 weeks', 'description': 'Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '26 weeks', 'description': 'Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12'}, {'measure': "Subject's Global Impression of Change", 'timeFrame': '26 weeks', 'description': 'Questionnaire that asks the subject to rate his or her impression of the effects of the study medication.'}, {'measure': "Clinician's Global Impression of Change", 'timeFrame': '26 weeks', 'description': 'Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication.'}, {'measure': 'VAS Pain Impact Scale', 'timeFrame': '26 weeks', 'description': 'A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating'}, {'measure': 'The Short Form McGill Pain Questionnaire (SF-MPQ)', 'timeFrame': '26 weeks', 'description': "A questionnaire with 3 components: a VAS to determine overall pain levels, a 15-word list of pain descriptors; and a Present Pain Intensity Scale to determine patient's pain at the time of survey completion"}, {'measure': 'Neuropathic Pain Questionnaire', 'timeFrame': '26 weeks', 'description': 'A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spasticity, Spinal Cord Injury'], 'conditions': ['Muscle Spasticity as a Result of Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.The study will be a phase 2, randomized, placebo-controlled crossover study. Each eligible subject will participate for 26 weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the opposite arm for another 11 week treatment period (phase 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal Cord Injury\n* 12 months post -injury\n* C2-T12, ASIA A-D, stable level of injury\n* moderate to severe spasticity or moderate to severe neuropathic pain\n* no cognitive impairment\n* spasticity medications unchanged for at least 30 days or inadequate pain control at a stabilized dose of either gabapentin or pregabalin for at least 30 days\n* no botulinum toxin injections x 6 months\n\nExclusion Criteria:\n\n* significant cardiovascular disease\n* major illness in another body area\n* history of psychological disorders or predisposition to psychosis\n* sensitivity to cannabinoids\n* severe liver disfunction\n* history of drug dependancy\n* fixed tendon contractures\n* used cannabis in the past 30 days\n* unwilling to refrain from smoking cannabis during the study\n* pregnant or nursing mother'}, 'identificationModule': {'nctId': 'NCT01222468', 'briefTitle': 'Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons', 'orgStudyIdInfo': {'id': '1976'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nabilone', 'description': 'nabilone 0.5 mg tablets dose-titrated over an 11-week period to a maximum of 3mg po daily. Subjects are allowed to drop back to the previous dose following a dose increase once if required', 'interventionNames': ['Drug: nabilone 0.5 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'look-alike 0.5 mg placebo tablets titrated to a maximum daily dose of 3.0 mg daily over an 11-week phase. Subjects are allowed to drop back to the previous dose following a dose increase once during the 11-week phase if required', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'nabilone 0.5 mg', 'type': 'DRUG', 'otherNames': ['Cesamet'], 'description': 'nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase', 'armGroupLabels': ['nabilone']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3A 1M4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Health Sciences Centre Rehabilitation Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Karen D. Ethans, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Manitoba Spinal Cord Injury Research Fund', 'class': 'UNKNOWN'}, {'name': 'Canadian Paraplegic Association', 'class': 'OTHER'}, {'name': 'Health Sciences Centre Foundation, Manitoba', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator MD', 'investigatorFullName': 'Dr. Karen Ethans', 'investigatorAffiliation': 'University of Manitoba'}}}}