Clinical Trial: Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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
Brief 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:
- To determine whether AV650 is safe for patients with spinal cord injury;
- To assess what the body does with AV650 once it is ingested; and,
- To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with spinal cord injury.
Detailed Summary:
Sponsor: Avigen
Current Primary Outcome: To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury. [ Time Frame: 1 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To determine preliminary efficacy in subjects with spasticity due to SCI [ Time Frame: 1 month ]
Original Secondary Outcome: Same as current
Information By: Avigen
Dates:
Date Received: September 14, 2007
Date Started: September 2007
Date Completion:
Last Updated: November 3, 2008
Last Verified: November 2008
