Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury

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.