Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
Study Details
Study Description
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:
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To determine whether AV650 is safe for patients with spinal cord injury;
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To assess what the body does with AV650 once it is ingested; and,
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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 |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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
Primary Outcome Measures
- To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury. [1 month]
Secondary Outcome Measures
- To determine preliminary efficacy in subjects with spasticity due to SCI [1 month]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects who provide written informed consent.
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Male or female subjects aged 18 to 70 years.
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In the judgment of the Principal Investigator, able to comply with protocol requirements.
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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).
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Neurological level between C-4 and T-12 spinal cord levels.
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SCI duration of 6 or more months.
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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.
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ASIA Impairment Scale Exam score of B, C or D.
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Female subjects of childbearing potential must be either surgically sterile or using an effective method of contraception.
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Female subjects of childbearing potential must have a negative urine pregnancy test at baseline (Study Day 0).
Exclusion Criteria:
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Subjects with a known hypersensitivity to lidocaine or non-steroidal analgesics.
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Subjects with clinically significant cardiovascular, pulmonary, endocrine, hepatic, renal, neurological, metabolic, or psychiatric disease.
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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.
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Any significant illness during the four weeks preceding Study Day 1.
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History of cancer or inflammatory arthritis of large joints.
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History of gastric or duodenal ulcer.
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Concurrent symptomatic urinary tract infections with fever.
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Severe physical injury, direct impact trauma, or neurological trauma within the last 6 months not including Spinal Cord Injury.
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ASIA Impairment Scale score of A or E.
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Uncontrolled hypertension or hypotension.
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Percussive tenderness of vertebral body or spinous process.
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Subjects with corrective surgery to or contracture of the measurable hip, knee, or ankle joints.
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Subjects known to be Hepatitis B or HIV positive.
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Female subjects who are pregnant or nursing.
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Subjects who have received an investigational drug within 30 days before Screening visit.
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Subjects with any documented episodes of seizures.
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Subjects requiring use of clinically relevant 2C19 or 2D6 inhibitors, or concomitant use of lidocaine.
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Use of rescue medication(s) within 48 hours of baseline procedures.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southern California Clinical Research, Inc. | Pasadena | California | United States | 91106 |
| 2 | University of Miami Miller School of Medicine | Miami | Florida | United States | 33136 |
| 3 | Shepherd Center, Inc. | Atlanta | Georgia | United States | 30309 |
| 4 | Internal Center for Spinal Cord Injury Kennedy Kreiger Institute | Baltimore | Maryland | United States | 21205 |
| 5 | Kernan Orthopaedics & Rehab. Hospital | Baltimore | Maryland | United States | 21207 |
| 6 | Kessler Institute for Rehab. | West Orange | New Jersey | United States | 07052 |
| 7 | Carolinas Rehabilitation | Charlotte | North Carolina | United States | 28203 |
| 8 | Jefferson Medical College of Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 9 | Hunter Holmes McGuire Veterans Affairs Medical Center | Richmond | Virginia | United States | 23249 |
| 10 | Rehabilitation Hospital Health Sciences Centre | Winnipeg | Quebec | Canada | R3A 1M4 |
Sponsors and Collaborators
- Avigen
Investigators
- Principal Investigator: Ralph J Marino, MD, Thomas Jefferson University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AV650-014