MedTrace Logo

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

NCT00531466 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-11-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Avigen

    lead INDUSTRY

Principal Investigators

  • Ralph J Marino, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00531466 on ClinicalTrials.gov