BOTOX® Treatment in Pediatric Upper Limb Spasticity

PHASE3CompletedINTERVENTIONAL
Enrollment

235

Participants

Timeline

Start Date

July 12, 2012

Primary Completion Date

June 29, 2017

Study Completion Date

July 6, 2017

Conditions
PediatricsMuscle SpasticityCerebral PalsyStroke
Interventions
BIOLOGICAL

botulinum toxin Type A

Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.

DRUG

Normal Saline (Placebo)

Intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1.

Trial Locations (45)

1104

Philippine Children's Medical Center, Bagong Pag-asa

4032

Debrecen University Clinical Center, Orthopedic Clinic, Debrecen

4114

De La Salle University Medical Center, Dasmariñas

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, Goyang-si

10700

Siriraj Hospital, Mahidol University, Bangkok

28203

OnSite Clinical Solutions, LLC, Charlotte

PMG Research if Charlotte, LLC, Charlotte

30342

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

32561

NW FL Clinical Research Group, LLC, Gulf Breeze

32891

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

50200

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

54449

Marshfield Clinic, Marshfield

55101

Gillette Children's Specialty Healthcare, Saint Paul

63110

Washington University School of Medicine, St Louis

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

91766

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

08043

Clinical Research Center of New Jersey, Voorhees Township

M4G 1R8

Holland Bloorview Kids Rehab, Toronto

80-219

Uni Centrum Kliniczne, Gdansk

30-359

Specjal. Gabinet Neurologiczny, Krakow

93-271

"Centrum Medyczne POMOC", Lodz

20-058

INTERMED, Lublin, Lublin

20-601

CRH ŻAGIEL MED, Lublin, Lublin

02-315

Neuro - 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

NCT01603602 - BOTOX® Treatment in Pediatric Upper Limb Spasticity | Biotech Hunter | Biotech Hunter