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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Muscle Spasticity

In brief

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.

Key facts

Study ID

NCT00531466

Run by

Avigen

People needed

120

Starts

2007-09-01

Expected to finish

2008-11-01

Last updated by the study team

2008-11-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.