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

Muscle Spasticity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00531466
• Other study ID #: AV650-014
• Status: Terminated
• Phase: Phase 2
• First received: September 14, 2007
• Last updated: November 3, 2008
• Start date: September 2007
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Avigen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Spinal Cord Injuries

Intervention

Drug:
• tolperisone HCl (AV650)
One tablet orally three times a day for 28 days
• Placebo
One tablet orally three times a day for 28 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Avigen

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury.		1 month	Yes
Secondary	To determine preliminary efficacy in subjects with spasticity due to SCI		1 month	Yes