Clinical trial NCT00531466: Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Muscle Spasticity
Keywords: Spinal cord injury
Lead sponsor: Avigen
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury.
timeFrame: 1 month
Secondary outcomes:
measure: To determine preliminary efficacy in subjects with spasticity due to SCI
timeFrame: 1 month
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Southern California Clinical Research, Inc.
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center, Inc.
state: Georgia
city: Baltimore
country: United States
facility: Internal Center for Spinal Cord Injury Kennedy Kreiger Institute
state: Maryland
city: Baltimore
country: United States
facility: Kernan Orthopaedics & Rehab. Hospital
state: Maryland
city: West Orange
country: United States
facility: Kessler Institute for Rehab.
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Rehabilitation
state: North Carolina
city: Philadelphia
country: United States
facility: Jefferson Medical College of Thomas Jefferson University
state: Pennsylvania
city: Richmond
country: United States
facility: Hunter Holmes McGuire Veterans Affairs Medical Center
state: Virginia
city: Winnipeg
country: Canada
facility: Rehabilitation Hospital Health Sciences Centre
state: Quebec
Study officials:
affiliation: Thomas Jefferson University
name: Ralph J Marino, MD
role: PRINCIPAL_INVESTIGATOR
References: