NCT00532532

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (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 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

Type	Name	Description
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

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-09-01
• Completion: 2008-11-01
• First posted: 2007-09-20
• Last updated: 2008-11-04

Locations

28 sites across 5 countries: Czechia, Germany, Russia, Serbia, Ukraine