Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
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ClinicalTrials.gov Identifier: NCT00531466 |
Recruitment Status
:
Terminated
First Posted
: September 18, 2007
Last Update Posted
: November 4, 2008
|
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A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following a spinal cord injury. This study has three purposes:
- To determine whether AV650 is safe for patients with spinal cord injury;
- To assess what the body does with AV650 once it is ingested; and,
- 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 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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531466
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 |
Principal Investigator: | Ralph J Marino, MD | Thomas Jefferson University |
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 Key Record Dates |
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 |