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Sponsored by: |
Avigen |
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Information provided by: | Avigen |
ClinicalTrials.gov Identifier: | NCT00531466 |
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following a spinal cord injury. This study has three purposes:
Condition | Intervention | Phase |
---|---|---|
Muscle Spasticity |
Drug: tolperisone HCl (AV650) Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 120 |
Study Start Date: | September 2007 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: tolperisone HCl (AV650)
One tablet orally three times a day for 28 days
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2: Placebo Comparator |
Drug: Placebo
One tablet orally three times a day for 28 days
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Southern California Clinical Research, Inc. | |
Pasadena, California, United States, 91106 | |
United States, Florida | |
University of Miami Miller School of Medicine | |
Miami, Florida, United States, 33136 | |
United States, Georgia | |
Shepherd Center, Inc. | |
Atlanta, Georgia, United States, 30309 | |
United States, Maryland | |
Kernan Orthopaedics & Rehab. Hospital | |
Baltimore, Maryland, United States, 21207 | |
Internal Center for Spinal Cord Injury Kennedy Kreiger Institute | |
Baltimore, Maryland, United States, 21205 | |
United States, New Jersey | |
Kessler Institute for Rehab. | |
West Orange, New Jersey, United States, 07052 | |
United States, North Carolina | |
Carolinas Rehabilitation | |
Charlotte, North Carolina, United States, 28203 | |
United States, Pennsylvania | |
Jefferson Medical College of Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Virginia | |
Hunter Holmes McGuire Veterans Affairs Medical Center | |
Richmond, Virginia, United States, 23249 | |
Canada, Quebec | |
Rehabilitation Hospital Health Sciences Centre | |
Winnipeg, Quebec, Canada, R3A 1M4 |
Principal Investigator: | Ralph J Marino, MD | Thomas Jefferson University Hospital |
Responsible Party: | Avigen, Inc. ( Robert Elfont, MD ) |
Study ID Numbers: | AV650-014 |
Study First Received: | September 14, 2007 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00531466 |
Health Authority: | United States: Food and Drug Administration |
Spinal cord injury |
Tolperisone Spinal Cord Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System Spinal Cord Injuries |
Signs and Symptoms Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neurologic Manifestations |
Neuromuscular Manifestations Therapeutic Uses Muscle Relaxants, Central Physiological Effects of Drugs Nervous System Diseases |
Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |