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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Muscle Spasticity	Drug: tolperisone HCl (AV650); Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	AV650-014: A Four Week, Prospective, Randomized, Double Blind, Placebo-Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV650 in Patients With Spasticity Due to Spinal Cord Injury
Study Start Date :	September 2007
Actual Primary Completion Date :	November 2008
Actual Study Completion Date :	November 2008

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 1	Drug: tolperisone HCl (AV650); One tablet orally three times a day for 28 days
Placebo Comparator: 2	Drug: Placebo; One tablet orally three times a day for 28 days

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. To determine preliminary efficacy in subjects with spasticity due to SCI [ Time Frame: 1 month ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, California
Southern California Clinical Research, Inc.
Pasadena, California, United States, 91106
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Shepherd Center, Inc.
Atlanta, Georgia, United States, 30309
United States, Maryland
Internal Center for Spinal Cord Injury Kennedy Kreiger Institute
Baltimore, Maryland, United States, 21205
Kernan Orthopaedics & Rehab. Hospital
Baltimore, Maryland, United States, 21207
United States, New Jersey
Kessler Institute for Rehab.
West Orange, New Jersey, United States, 07052
United States, North Carolina
Carolinas Rehabilitation
Charlotte, North Carolina, United States, 28203
United States, Pennsylvania
Jefferson Medical College of Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States, 23249
Canada, Quebec
Rehabilitation Hospital Health Sciences Centre
Winnipeg, Quebec, Canada, R3A 1M4

Sponsors and Collaborators

Avigen

Investigators

Principal Investigator:	Ralph J Marino, MD	Thomas Jefferson University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Robert Elfont, MD, Avigen, Inc.
ClinicalTrials.gov Identifier:	NCT00531466 History of Changes
Other Study ID Numbers:	AV650-014
First Posted:	September 18, 2007
Last Update Posted:	November 4, 2008
Last Verified:	November 2008

Keywords provided by Avigen:

Spinal cord injury

Additional relevant MeSH terms:

Muscle Spasticity; Spinal Cord Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases	Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Tolperisone; Muscle Relaxants, Central; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents