BOTOX® Treatment in Pediatric Lower Limb Spasticity

PHASE3CompletedINTERVENTIONAL
Enrollment

384

Participants

Timeline

Start Date

September 11, 2012

Primary Completion Date

June 28, 2017

Study Completion Date

June 28, 2017

Conditions
PediatricsMuscle SpasticityCerebral Palsy
Interventions
BIOLOGICAL

botulinum toxin Type A

Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.

DRUG

Normal Saline (Placebo)

Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.

Trial Locations (53)

1100

Philippine Orthopedic Center, Quezon City

1102

St. Luke's Medical Center-Quezon City, Quezon City

1104

Philippine Children's Medical Center, Quezon City

1113

Semmelweis Egyetem- Ortopédiai Klinika, 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 Medical Center Dept. of Rehab. & Regenerative Medicine, New York

10444

National Health Insurance Service Ilsan Hospital, Gyeonggi-do

16148

Istituto IRCCS G. Gaslini, 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, PA, Orlando

33470

Axcess Medical Research, LLC, Loxahatchee Groves

37232

Vanderbilt University Medical Center, Nashville

40002

Srinagarind Hospital, Khon Kaen University, Khon Kaen

41199

Daegu Fatima Hospital, Daegu

41380

Kocaeli Üniversitesi, Kocaeli

42250

Selçuk Üniversitesi, Konya

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai

54449

Marshfield Clinic, Marshfield

60611

Rehab Institute of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

64108

The Children's Mercy Hospital & Clinics, Kansas City

75235

University of Texas Southwestern Medical Center, Dallas

77030

Baylor College of Medicine Texas Children's Hospital, Houston

78258

Road Runner Research, San Antonio

80045

Children's Hospital Colorado Dept. of PM&R, Aurora

91106

AMS Neurology, Pasadena

91767

Harrison Clinical Management, Pomona

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 CT, P.C., Fairfield

06905

New England Center for Clinical Research, Stamford

08043

Clinical Research Center of New Jersey, Voorhees Township

02903

Rhode Island Hospital, Providence

15-274

Uniwersytecki Dzieciecy Szpita, Bialystok

80-219

Uni Centrum Kliniczne, Gdansk

80-389

Centrum Rehabilitacji Krok po Kroku, Gdansk

30-359

Specjal. Gabinet Neurologiczny, Krakow

20-058

INTERMED, Lublin, Lublin

20-601

CRH ŻAGIEL MED, Lublin, Lublin

35-301

Szpital Wojewódzki Nr 2, Rzeszów

02-315

Neuro - Dzieci I Mlodziezy Aga, Warsaw

05-462

NZOZ Mazowieckie Centrum, Warsaw

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

120-752

Severance Hospital, Yonsei University Health System, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allergan

INDUSTRY