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Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis

NCT00532532 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

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 associated with multiple sclerosis. This study has three purposes:

1. To determine whether AV650 is safe for patients with multiple sclerosis;
2. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with multiple sclerosis; and,
3. To assess what the body does with AV650 once it is ingested (Germany and Czech Republic sites only).

Conditions

  • Muscle Spasticity

Interventions

DRUG

tolperisone HCl

Low dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks

DRUG

tolperisone HCl

High dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks

DRUG

tolperisone HCl

Placebo three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks

Sponsors & Collaborators

  • Avigen

    lead INDUSTRY

Principal Investigators

  • Glenn Morrison, MSc, PhD · Avigen, Inc.

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
2008-09-30
Completion
2008-11-30

Countries

  • Czechia
  • Germany
  • Russia
  • Serbia
  • Ukraine

Study Locations

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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 NCT00532532 on ClinicalTrials.gov