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

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avigen
• Treatments: Tolperisone

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.