Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-28 @ 8:15 AM
Study NCT ID:
NCT00531466
Status:
TERMINATED
Last Update Posted:
2008-11-04
First Post:
2007-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
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': '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': 120}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-03', 'studyFirstSubmitDate': '2007-09-14', 'studyFirstSubmitQcDate': '2007-09-17', 'lastUpdatePostDateStruct': {'date': '2008-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury.', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'To determine preliminary efficacy in subjects with spasticity due to SCI', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal cord injury'], 'conditions': ['Muscle Spasticity']}, 'descriptionModule': {'briefSummary': 'A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following a spinal cord injury. This study has three purposes:\n\n1. To determine whether AV650 is safe for patients with spinal cord injury;\n2. To assess what the body does with AV650 once it is ingested; and,\n3. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who provide written informed consent.\n* Male or female subjects aged 18 to 70 years.\n* In the judgment of the Principal Investigator, able to comply with protocol requirements.\n* Subjects willing and able to withdraw from other anti-spasmodic/muscle relaxant drugs for at least two weeks before randomization (including but not limited to baclofen, benzodiazepines, clonazepam, clonidine, dantrolene, diazepam, gabapentin, and tizanidine).\n* Neurological level between C-4 and T-12 spinal cord levels.\n* SCI duration of 6 or more months.\n* Muscle tone sufficient to score at least two (2) on the Ashworth Scale for at least one of the following lower muscle groups: ankle plantar flexors (gastrocnemius), knee extensors (quadriceps), knee flexors (hamstrings) and/or hip adductors (adductors) and seven (7) for the most spastic limb.\n* ASIA Impairment Scale Exam score of B, C or D.\n* Female subjects of childbearing potential must be either surgically sterile or using an effective method of contraception.\n* Female subjects of childbearing potential must have a negative urine pregnancy test at baseline (Study Day 0).\n\nExclusion Criteria:\n\n* Subjects with a known hypersensitivity to lidocaine or non-steroidal analgesics.\n* Subjects with clinically significant cardiovascular, pulmonary, endocrine, hepatic, renal, neurological, metabolic, or psychiatric disease.\n* Any recent history of mental illness, drug addiction, recreational drug use, or alcoholism and/or any similar condition that the investigator feels should prohibit study participation.\n* Any significant illness during the four weeks preceding Study Day 1.\n* History of cancer or inflammatory arthritis of large joints.\n* History of gastric or duodenal ulcer.\n* Concurrent symptomatic urinary tract infections with fever.\n* Severe physical injury, direct impact trauma, or neurological trauma within the last 6 months not including Spinal Cord Injury.\n* ASIA Impairment Scale score of A or E.\n* Uncontrolled hypertension or hypotension.\n* Percussive tenderness of vertebral body or spinous process.\n* Subjects with corrective surgery to or contracture of the measurable hip, knee, or ankle joints.\n* Subjects known to be Hepatitis B or HIV positive.\n* Female subjects who are pregnant or nursing.\n* Subjects who have received an investigational drug within 30 days before Screening visit.\n* Subjects with any documented episodes of seizures.\n* Subjects requiring use of clinically relevant 2C19 or 2D6 inhibitors, or concomitant use of lidocaine.\n* Use of rescue medication(s) within 48 hours of baseline procedures.'}, 'identificationModule': {'nctId': 'NCT00531466', 'briefTitle': 'Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avigen'}, 'officialTitle': 'AV650-014: A Four Week, Prospective, Randomized, Double Blind, Placebo-Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV650 in Patients With Spasticity Due to Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'AV650-014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: tolperisone HCl (AV650)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'tolperisone HCl (AV650)', 'type': 'DRUG', 'description': 'One tablet orally three times a day for 28 days', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One tablet orally three times a day for 28 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91106', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Clinical Research, Inc.', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Shepherd Center, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Internal Center for Spinal Cord Injury Kennedy Kreiger Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21207', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Kernan Orthopaedics & Rehab. Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '07052', 'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kessler Institute for Rehab.', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Rehabilitation', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Medical College of Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire Veterans Affairs Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': 'R3A 1M4', 'city': 'Winnipeg', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Rehabilitation Hospital Health Sciences Centre'}], 'overallOfficials': [{'name': 'Ralph J Marino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avigen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Robert Elfont, MD', 'oldOrganization': 'Avigen, Inc.'}}}}