108
Participants
Start Date
February 28, 2006
Primary Completion Date
January 31, 2008
Study Completion Date
January 31, 2008
Botulinum toxin type A
In this long-term extension study, a dose of 500 units Dysport was administered by intramuscular injection into the clinically indicated neck muscles in a single dosing session in the first treatment cycle. This was the same dose as given in the preceding study NCT00257660 (Y-47-52120-051). Based on individual safety \& efficacy, subjects could then receive up to 3 subsequent injections with doses titrated in 250 unit steps, to a minimum of 250 units and a maximum of 1000 units. Retreatment occurred approximately 12-16 weeks after the previous injection, with the exact timing based on clinical need.
Beth Israel Medical Center, New York
Columbia University Medical Center, Neurological Institute, New York
Albany Medical Center, Albany
Allegheny General Hospital, Pittsburgh
Emory University School of Medicine, Wesley Woods Health Center, Atlanta
University of Florida, Dept of Neurology, Gainesville
University of Miami, Dept of Neurology, Miami
Wayne State University Medical Center, Southfield
University of Iowa, Dept of Neurology, Iowa City
University of Texas Southwest Medical Center, Movement Disorder Clinic, Dallas
Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic, Houston
Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center, Phoenix
USC School of Medicine, Los Angeles
The Parkinson's and Movement Disorder Institute, Fountain Valley
Scientific Research Institute of Neurology, RAMS, Moscow
"Clinic Cecil Plus", Moscow
Municipal Multi-Speciality Hospital #2, Saint Petersburg
St Petersburg Pavlov State Medical University, Saint Petersburg
Lead Sponsor
Ipsen
INDUSTRY