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

Muscle Spasticity Clinical Trial

Official title:
AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis

Clinical Trial 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).

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 NCT00532532
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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