Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-02 @ 6:07 PM
Study NCT ID:
NCT00532532
Status:
TERMINATED
Last Update Posted:
2008-11-04
First Post:
2007-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014049', 'term': 'Tolperisone'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-03', 'studyFirstSubmitDate': '2007-09-18', 'studyFirstSubmitQcDate': '2007-09-18', 'lastUpdatePostDateStruct': {'date': '2008-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the long-term safety and tolerability of AV650 (tolperisone HCl) in subjects with spasticity associated with MS', 'timeFrame': '38 weeks'}], 'secondaryOutcomes': [{'measure': 'To determine preliminary efficacy of AV650 as compared to placebo in subjects with spasticity associated with MS; and to determine the pharmacokinetic (PK) profile of AV650 at two dose levels', 'timeFrame': '38 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis'], 'conditions': ['Muscle Spasticity']}, 'descriptionModule': {'briefSummary': 'A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity associated with multiple sclerosis. This study has three purposes:\n\n1. To determine whether AV650 is safe for patients with multiple sclerosis;\n2. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with multiple sclerosis; and,\n3. To assess what the body does with AV650 once it is ingested (Germany and Czech Republic sites only).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects between 18 and 70 years of age (inclusive)\n* Signed and dated informed consent\n* Definite MS as per Poser or MacDonald Criteria (either relapsing remitting or secondary progressive course)\n* Expanded Disability Status Score (EDSS) from 3.0 to 6.5 (inclusive) at Screening\n* Stable MS for at least 30 days before screening\n* Female of child bearing potential and male subjects whose partner is of child bearing potential who are willing to ensure that they or their partner use effective double-barrier contraception during the study and for 90 days thereafter\n* If female, be neither pregnant nor nursing (Confirmation that the subject is not pregnant must be established by a negative serum hCG pregnancy test at baseline.)\n* Significant spasticity in at least two muscle groups defined as a score of 2 or more on the Ashworth scale for each muscle group\n* If a subject is on anti-spastic treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening\n* If a subject is on MS treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening\n\nExclusion Criteria:\n\n* Subjects who have participated in another research study within 90 days of Screening\n* Significant changes in anti-spasticity medications (dosage, frequency, or route of administration) within 30 days of Screening\n* Known hypersensitivity to tolperisone HCl, its components, or other lidocaine/lidocaine-like products\n* Use of tolperisone HCl within 30 days of screening\n* Significant changes in MS treatments (dosage, frequency, or route of administration) within 30 days of Screening\n* Spasticity due to neurological disorders other than MS\n* Any psychiatric disorder or cognitive impairment that precludes fully informed consent or safe participation in the study\n* Subjects who have suffered an acute relapse of MS or who continue to suffer from an acute relapse of MS within 90 days of Baseline\n* History of alcohol or substance abuse within one year of Screening\n* Concurrent clinically significant immunologic, pulmonary, renal, hepatic, or endocrine disease and/or other unstable or major disease other than MS\n* Clinically significant cardiovascular disorders, such as ischemic heart disease, arrhythmias, poorly controlled hypertension, or acute myocardial infarction\n* QT prolongation greater than 480 msec or greater than 450 msec if accompanied by a partial bundle branch block, or other ECG abnormality in the judgment of the Investigator\n* Diastolic blood pressure \\<50mmHg or \\>105mmHg; heart rate \\<50 beats per minute (bpm) or \\>110bpm, after 3 minutes in a sitting position; heart rate by ECG \\<50bpm or \\>110bpm\n* History of epilepsy (except childhood febrile seizures)\n* Current malignancy or history of malignancy that has not been in remission for more than five years, except basal cell skin carcinoma and cervical cancer (with treatment)\n* Female subject who is pregnant, nursing, or planning pregnancy during the course of the study\n* Scheduled elective surgery or other procedures requiring general anesthesia during the study\n* Subject who is terminally ill in the judgment of the Investigator\n* Subject who is inappropriate for placebo medication in the judgment of the Investigator\n* Systemic corticosteroid therapy within 28 days of randomization, with the exception of inhaled medications for asthma\n* Exacerbation of MS within 30 days of Baseline\n* Regular levo-dopa therapy within 7 days of randomization\n* Subjects taking antiarrhythmic medications\n* Donation of blood during the study'}, 'identificationModule': {'nctId': 'NCT00532532', 'briefTitle': 'Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avigen'}, 'officialTitle': 'AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'AV650-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AV650 low dose', 'interventionNames': ['Drug: tolperisone HCl']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'AV650 high dose', 'interventionNames': ['Drug: tolperisone HCl']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Drug: tolperisone HCl']}], 'interventions': [{'name': 'tolperisone HCl', 'type': 'DRUG', 'description': 'Low dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks', 'armGroupLabels': ['1']}, {'name': 'tolperisone HCl', 'type': 'DRUG', 'description': 'High dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks', 'armGroupLabels': ['2']}, {'name': 'tolperisone HCl', 'type': 'DRUG', 'description': 'Placebo three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Annes University Hospital', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'University Hospital Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '30460', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'University Hospital Plzen', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '15006', 'city': 'Prague', 'country': 'Czechia', 'facility': 'University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '15526', 'city': 'Bad Saarow', 'country': 'Germany', 'facility': 'Facharzt fur Neurologie', 'geoPoint': {'lat': 52.28333, 'lon': 14.06667}}, {'zip': '12555', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Facharztin fur Neurologie und Psychiatrie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13053', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Facharzt fur Neurologie und Psychiatrie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-13156', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Private practice', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44805', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Neurological practice', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '50767', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Neurological practice', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40212', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Neuro-Consil GmbH', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '82166', 'city': 'Gräfelfing', 'country': 'Germany', 'facility': 'X-pert-med GmbH', 'geoPoint': {'lat': 48.11878, 'lon': 11.42939}}, {'zip': 'D022417', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik Nord-Heidberg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '603076', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'City Hospital #33', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '603126', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Regional Clinical Hospital named Semashko', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Institute of Human Brain', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197376', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Leningrad Regional Clinical Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198510', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Nikolaevskaya Hospital, Complex Rehabilitation Department', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Center of Serbia Institute of Neurology', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '18000', 'city': 'Niš', 'country': 'Serbia', 'facility': 'Clinical Center Nis Clinic of Neurology', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}, {'zip': '76008', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Ivano-Frankivsk Regional Clinical Hospital', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '61018', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Central Clinical Hospital Ukrzalinznytsi (Dept. Neur. No. 1)', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61018', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Central Clinical Hospital Ukrzalinznytsi (Dept. Neur. No. 3)', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61068', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '03115', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Institute of Clinical Radiology of the Scientific Centre of Radiation Medicine of the AMS of Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '65014', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Odesa Regional Psychoneurological Dispensary', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '95017', 'city': 'Simferopol', 'country': 'Ukraine', 'facility': 'M.O.Semashko Republican Clinical Hospital', 'geoPoint': {'lat': 44.95719, 'lon': 34.11079}}, {'zip': '88018', 'city': 'Uzhhorod', 'country': 'Ukraine', 'facility': 'Uzhgorod Regional Centre of Neurosurgery and Neurology', 'geoPoint': {'lat': 48.6242, 'lon': 22.2947}}], 'overallOfficials': [{'name': 'Glenn Morrison, MSc, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avigen, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avigen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Glenn Morrison, Ph.D.', 'oldOrganization': 'Avigen, Inc.'}}}}