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

Phase 2

Terminated

• Conditions: Muscle Spasticity
• Interventions: Drug: tolperisone HCl (AV650); Drug: Placebo

• Registration Number: NCT00531466
• Lead Sponsor: Avigen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-14
• Study First Submitted QC: 2007-09-17
• Study First Posted: 2007-09-18
• Status Verified: 2008-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Last Update Submitted: 2008-11-03
• Last Update Posted: 2008-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tolperisone HCl (AV650)	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury.	1 month

Secondary Outcome Measures

Name	Time	Method
To determine preliminary efficacy in subjects with spasticity due to SCI	1 month

Trial Locations

Locations (10)

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