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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 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.

Clinical Trial Description

n/a

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

Clinical Trial Details
NCT number NCT00531466
Study type Interventional
Source Avigen
Contact
Status Terminated
Phase Phase 2
Start date September 2007
Completion date November 2008
View Details
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