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

NCT00531466 | Terminated Phase 2

• 1 other identifier: AV650-014
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 10

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. 1.To determine whether AV650 is safe for patients with spinal cord injury;
2. 2.To assess what the body does with AV650 once it is ingested; and,
3. 3.To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with spinal cord injury.

Conditions

Muscle Spasticity

Keywords

Spinal cord injury

Outcome Measures

Primary Outcomes (1)

• To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury.

  1 month

Secondary Outcomes (1)

• To determine preliminary efficacy in subjects with spasticity due to SCI

  1 month

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: tolperisone HCl (AV650)

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

tolperisone HCl (AV650) DRUG

One tablet orally three times a day for 28 days

1

Placebo DRUG

One tablet orally three times a day for 28 days

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Avigen: lead

Study Sites (10)

Southern California Clinical Research, Inc.

Pasadena, California, 91106, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Shepherd Center, Inc.

Atlanta, Georgia, 30309, United States

Location

Internal Center for Spinal Cord Injury Kennedy Kreiger Institute

Baltimore, Maryland, 21205, United States

Location

Kernan Orthopaedics & Rehab. Hospital

Baltimore, Maryland, 21207, United States

Location

Kessler Institute for Rehab.

West Orange, New Jersey, 07052, United States

Location

Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Location

Jefferson Medical College of Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Hunter Holmes McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

Rehabilitation Hospital Health Sciences Centre

Winnipeg, Quebec, R3A 1M4, Canada

Location

MeSH Terms

Conditions

Muscle Spasticity; Spinal Cord Injuries

Interventions

Tolperisone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ralph J Marino, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 14, 2007
• First Posted: September 18, 2007
• Study Start: September 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 4, 2008

Record last verified: 2008-11

Locations

US (9); CA (1)