safety and preliminary effectiveness of av650 in patients with spasticity due to spinal cord injury

Conditions: Muscle Spasticity

Summary: a drug called av650 (tolperisone hcl) will be given to patients who have spasticity following a spinal cord injury. this study has three purposes: 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.


Eligibility criteria:
inclusion criteria: * subjects who provide written informed consent. * 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 a known hypersensitivity to lidocaine or non-steroidal analgesics. * 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.

Keywords: spinal cord injury