BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

PHASE3CompletedINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

November 5, 2012

Primary Completion Date

August 25, 2018

Study Completion Date

August 25, 2018

Conditions
PediatricsMuscle SpasticityCerebral Palsy
Interventions
BIOLOGICAL

Botulinum Toxin Type A

Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.

Trial Locations (56)

1100

Philippine Orthopedic Center, Quezon City

1102

St. Luke's Medical Center, Quezon City

1104

Philippine Children's Medical Center, Quezon City

1113

Semmelweis Egyetem- Ortopédiai Klinika Karolina út 27, Budapest

4032

Debrecen University Clinical Center, Orthopedic Clinic, Debrecen

6110

Ankara Diskapi Yildrim Beyazit, Ankara

10003

NYU Hospital for Joint Diseases, New York

10032

Columbia University Dept. of Rehab. & Regenerative Medicine, New York

10444

National Health Insurance Service Ilsan Hospital, Gyeonggi-do

16148

Istituto IRCCS G. Salini, Genoa

28203

OnSite Clinical Solutions, LLC, Charlotte

PMG Research of Charlotte, LLC, Charlotte

30342

Children's Healthcare of Atlanta Children's Rehabilitation Associates, Atlanta

32561

NW FL Clinical Research Group, LLC, Gulf Breeze

32819

Pediatric Neurology, P.A., Orlando

33470

Axcess Medical Research, LLC, Loxahatchee Groves

37232

Vanderbilt University Medical Center, Nashville

40002

Srinagarind Hospital, Khon Kaen University, Khon Kaen

41050

Kocaeli Üniversitesi, Kocaeli

41199

Daegu Fatima Hospital, Daegu

42250

Selçuk Üniversitesi, Konya

48073

Beaumont Children's Hospital Pediatric Research, Royal Oak

50200

Maharaj Nakorn ChiangMai Hospital, Chiang Mai

54449

Marshfield Clinic, Marshfield

60611

Shirley Ryan Ability Lab, Chicago

63110

Washington University School of Medicine, St Louis

64108

The Children's Mercy Hospital, Kansas City

75390

University of Texas Southwestern Medical Center, Dallas

77030

Baylor College of Medicine Texas Children's Hospital, Houston

78249

Road Runner Research, San Antonio

80045

Children's Hospital Colorado, Aurora

91106

ABS Health, LLC, Pasadena

91767

Harrison Clinical Management, Pomona

92123

Rady Children's Hospital San Diego, San Diego

98105

Seattle Children's Hospital, Seattle

214018

Smolensk Regional Hospital- Regional Budget State Healthcare institution, Smolensk

420138

Childrens Republic Hospital, Kazan'

625039

Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region, Tyumen

06824

Associated Neurologists of Southern Connecticut, P.C., Fairfield

06905

New England Institute for Clinical Research, Stamford

08043

Clinical Research Center of New Jersey, Voorhees Township

02903

Hasbro Children's Hospital, Providence

15-274

Uniwersytecki Dzieciecy Szpita, Bialystok

80-219

Uniwersyteckie Centrum Kliniczne, Gdansk

80-389

Centrum Rehabilitacji Krok po Kroku, Gdansk

30-539

Specjalistyczny Gabinet Neurologiczny, Krakow

93-271

"Centrum Medyczne POMOC", Lodz

20-058

INTERMED, Lublin, Lublin

20-601

CRH ŻAGIEL MED, Lublin, Lublin

35-301

Szpital Wojewodzki Nr 2, Rzeszów

02-315

Poradnia Rehab - Neurologiczneij dla Dzieci I Mlodziezy Aga, Warsaw

05-462

NZOZ Mazowieckie Centrum, Warsaw

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allergan

INDUSTRY