Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
NCT ID: NCT00531466
Last Updated: 2008-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
120 participants
INTERVENTIONAL
2007-09-30
2008-11-30
Brief Summary
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1. To determine whether AV650 is safe for patients with spinal cord injury;
2. To assess what the body does with AV650 once it is ingested; and,
3. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with spinal cord injury.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
tolperisone HCl (AV650)
One tablet orally three times a day for 28 days
2
Placebo
One tablet orally three times a day for 28 days
Interventions
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tolperisone HCl (AV650)
One tablet orally three times a day for 28 days
Placebo
One tablet orally three times a day for 28 days
Eligibility Criteria
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Inclusion Criteria
* Male or female subjects aged 18 to 70 years.
* In the judgment of the Principal Investigator, able to comply with protocol requirements.
* 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).
* Neurological level between C-4 and T-12 spinal cord levels.
* SCI duration of 6 or more months.
* 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.
* ASIA Impairment Scale Exam score of B, C or D.
* Female subjects of childbearing potential must be either surgically sterile or using an effective method of contraception.
* Female subjects of childbearing potential must have a negative urine pregnancy test at baseline (Study Day 0).
Exclusion Criteria
* Subjects with clinically significant cardiovascular, pulmonary, endocrine, hepatic, renal, neurological, metabolic, or psychiatric disease.
* 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.
* Any significant illness during the four weeks preceding Study Day 1.
* History of cancer or inflammatory arthritis of large joints.
* History of gastric or duodenal ulcer.
* Concurrent symptomatic urinary tract infections with fever.
* Severe physical injury, direct impact trauma, or neurological trauma within the last 6 months not including Spinal Cord Injury.
* ASIA Impairment Scale score of A or E.
* Uncontrolled hypertension or hypotension.
* Percussive tenderness of vertebral body or spinous process.
* Subjects with corrective surgery to or contracture of the measurable hip, knee, or ankle joints.
* Subjects known to be Hepatitis B or HIV positive.
* Female subjects who are pregnant or nursing.
* Subjects who have received an investigational drug within 30 days before Screening visit.
* Subjects with any documented episodes of seizures.
* Subjects requiring use of clinically relevant 2C19 or 2D6 inhibitors, or concomitant use of lidocaine.
* Use of rescue medication(s) within 48 hours of baseline procedures.
18 Years
70 Years
ALL
No
Sponsors
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Avigen
INDUSTRY
Responsible Party
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Avigen, Inc.
Principal Investigators
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Ralph J Marino, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Southern California Clinical Research, Inc.
Pasadena, California, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Shepherd Center, Inc.
Atlanta, Georgia, United States
Internal Center for Spinal Cord Injury Kennedy Kreiger Institute
Baltimore, Maryland, United States
Kernan Orthopaedics & Rehab. Hospital
Baltimore, Maryland, United States
Kessler Institute for Rehab.
West Orange, New Jersey, United States
Carolinas Rehabilitation
Charlotte, North Carolina, United States
Jefferson Medical College of Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States
Rehabilitation Hospital Health Sciences Centre
Winnipeg, Quebec, Canada
Countries
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Other Identifiers
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AV650-014
Identifier Type: -
Identifier Source: org_study_id