NCT00531466

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Avigen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Muscle Spasticity

Interventions

Type	Name	Description
DRUG	tolperisone HCl (AV650)	One tablet orally three times a day for 28 days
DRUG	Placebo	One tablet orally three times a day for 28 days

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-09-18
• Last updated: 2008-11-04

Locations

10 sites across 2 countries: United States, Canada