Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-03 @ 6:47 PM
Study NCT ID:
NCT00552604
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
2007-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D010146', 'term': 'Pain'}], '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': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}}, 'statusModule': {'whyStopped': 'due to recruitment problems / based on recommendation of Independent Review Board', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2007-11-01', 'studyFirstSubmitQcDate': '2007-11-01', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in muscle stiffness: 11-point numerical Likert scale', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in pain: 11-point numerical Likert scale', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'muscle stiffness', 'spasticity', 'pain', 'treatment', 'cannabinoids'], 'conditions': ['Muscle Spasticity']}, 'referencesModule': {'references': [{'pmid': '22791906', 'type': 'DERIVED', 'citation': 'Zajicek JP, Hobart JC, Slade A, Barnes D, Mattison PG; MUSEC Research Group. Multiple sclerosis and extract of cannabis: results of the MUSEC trial. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1125-32. doi: 10.1136/jnnp-2012-302468. Epub 2012 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'Study Objectives: To determine the efficacy and safety of a standardised extract of Cannabis sativa given orally 2 times daily as compared to placebo for the relief of muscle stiffness and pain in multiple sclerosis for a period of 12 weeks.\n\nStudy Patients: 400 patients with multiple sclerosis (age 18-64, stable disease during previous 6 months, ambulatory or not, antispasticity medication and physiotherapy stabilised ≥ 30 days) with experiencing muscle stiffness ≥ 4 on a 11-point numerical Likert scale at baseline.\n\nStudy treatment:\n\nGroup 1: Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily, additionally to previous antispasticity and analgesic medication.\n\nGroup 2: Matched placebo, twice daily, additionally to previous antispasticity and analgesic medication.\n\nTreatment Schedule: Start dose 5 mg THC/d, individual dose titration with increase of 5 mg THC every 3 days, maximal total daily dose 25 mg THC, administered as 2 equal doses based on tolerability. Treatment duration: 12 weeks.\n\nStudy sites: 20 neurological clinics in the United Kingdom.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent.\n* Diagnosis of MS according to McDonald criteria.\n* Current muscle stiffness ≥ 4 on a 11-point categorical rating scale.\n* On-going troublesome muscle stiffness for at least 3 months.\n* Stable disease for the previous 6 months.\n* Antispasticity medication and physiotherapy stabilised for the last 30 days.\n* Patients may be ambulatory or not.\n* Age 18-64.\n\nExclusion Criteria:\n\n* Immunosuppressants which may affect spasticity (including corticosteroids and interferon but ex-cluding azathioprine) taken currently or in previous 30 days\n* Past or present history of psychotic illness.\n* Open/infected pressure sores or other source of chronic infection.\n* Significant fixed tendon contractures.\n* Severe cognitive impairment such that the patient is unable to provide informed consent.\n* History of clinically important renal, cardiovascular or neurol. diseases (apart from MS).\n* Malignancy within the past 2 years.\n* Cannabinoids taken currently or in previous 30 days.\n* Positive qualitative urinary test on cannabinoids at screening visit. (In this case a patient will be allowed to repeat the test at a second screening visit later.)\n* Known hypersensitivity to cannabinoids.\n* Current drug abuse, including alcohol abuse.\n* Laboratory parameters outside the following limits:\n\nCreatinine \\> 3x upper limit of normal Bilirubine \\> 3x upper limit of normal Transaminases \\> 5 x upper limit of normal\n\n* Anticipated immunisations within the 12 weeks of trial participation.\n* Other problems likely to make participation difficult at the discretion of the neurologist.\n* Women who are pregnant, lactating or not using adequate contraception.\n* Participation in other treatment studies currently or within the previous month.'}, 'identificationModule': {'nctId': 'NCT00552604', 'acronym': 'MUSEC', 'briefTitle': 'MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study', 'organization': {'class': 'OTHER', 'fullName': 'Institut fur Klinische Forschung, Germany'}, 'officialTitle': 'Randomised, Double-blind, Placebo-controlled Phase III Trial to Determine the Efficacy and Safety of a Standardised Oral Extract of Cannabis Sativa for the Symptomatic Relief of Muscle Stiffness and Pain in Multiple Sclerosis.', 'orgStudyIdInfo': {'id': '25-01'}, 'secondaryIdInfos': [{'id': 'EUDRA-CT No.'}, {'id': '2005-005263-29'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily', 'interventionNames': ['Drug: standardized cannabis extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'matching placebo capsules, twice daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'standardized cannabis extract', 'type': 'DRUG', 'description': 'Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo capsules, twice daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PL6 8BX', 'city': 'Plymouth', 'state': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Peninsula Medical School', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'John J Zajicek, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peninsula Medical School, University of Plymouth, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut fur Klinische Forschung, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Weleda AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}