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

PHASE2TerminatedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

November 30, 2008

Study Completion Date

November 30, 2008

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

Trial Locations (10)

19107

Jefferson Medical College of Thomas Jefferson University, Philadelphia

21205

Internal Center for Spinal Cord Injury Kennedy Kreiger Institute, Baltimore

21207

Kernan Orthopaedics & Rehab. Hospital, Baltimore

23249

Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond

28203

Carolinas Rehabilitation, Charlotte

30309

Shepherd Center, Inc., Atlanta

33136

University of Miami Miller School of Medicine, Miami

91106

Southern California Clinical Research, Inc., Pasadena

07052

Kessler Institute for Rehab., West Orange

R3A 1M4

Rehabilitation Hospital Health Sciences Centre, Winnipeg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Avigen

INDUSTRY

NCT00531466 - Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury | Biotech Hunter | Biotech Hunter