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BOTOX® Treatment in Pediatric Upper Limb Spasticity

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ClinicalTrials.gov Identifier: NCT01603602
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.

Condition or disease Intervention/treatment Phase
Pediatrics Muscle Spasticity Cerebral Palsy Stroke Biological: botulinum toxin Type A Drug: Normal Saline (Placebo) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BOTOX® Treatment in Pediatric Upper Limb Spasticity: Double-blind Study
Study Start Date : July 12, 2012
Actual Primary Completion Date : June 29, 2017
Actual Study Completion Date : July 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: BOTOX® 3 U/kg
Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U per kg of body weight (3 U/kg) into specified muscles of the upper limb.
Biological: botulinum toxin Type A
Subjects will receive intramuscular injections of botulinum toxin Type A 3 U per kg of body weight (3 U/kg) into specified muscles of the upper limb.
Other Name: BOTOX®

Experimental: BOTOX® 6 U/kg
Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb.
Biological: botulinum toxin Type A
Subjects will receive intramuscular injections of botulinum toxin Type A 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb.
Other Name: BOTOX®

Placebo Comparator: Placebo
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the upper limb.
Drug: Normal Saline (Placebo)
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the upper limb.




Primary Outcome Measures :
  1. Change from Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ]
  2. Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale [ Time Frame: Baseline, 6 Weeks ]

Secondary Outcome Measures :
  1. Change from Baseline in MAS-B Score of the Finger Flexor Muscle Group Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ]
  2. Goal Attainment Score as Assessed by Physician Using a 6-Point Scale [ Time Frame: Week 12 ]
  3. Change from Baseline in Severity of Spasticity of the Principal Muscle Group Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline, 6 Weeks ]


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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum weight of 10 kg/22 lb
  • Upper limb spasticity due to cerebral palsy or stroke

Exclusion Criteria:

  • Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease
  • Uncontrolled epilepsy
  • Botulinum Toxin therapy of any serotype for any condition within the last 6 months
  • Previous surgical treatment of the study limb (except tendon lengthening), or planned surgery of the study limb during the study
  • Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected lower limb during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603602


  Hide Study Locations
Locations
United States, California
AMS Neurology
Pasadena, California, United States, 91106
Harrison Clinical Management
Pomona, California, United States, 91766
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
United States, Colorado
Children's Hospital Colorado Dept. of PM&R
Aurora, Colorado, United States, 80045
Children's Hospital Colorado PM&R
Aurora, Colorado, United States, 80045
United States, Connecticut
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, United States, 06824
New England Center for Clinical Research
Stamford, Connecticut, United States, 06905
United States, Florida
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States, 32561
Axcess Medical Research, LLC
Loxahatchee Groves, Florida, United States, 33470
Pediatric Neurology, PA
Orlando, Florida, United States, 32891
United States, Georgia
Children's Healthcare of Atlanta Children's Rehabilitation Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
Rehab Institute of Chicago
Chicago, Illinois, United States, 60611
United States, Michigan
Beaumont Children's Hospital Pediatric Research
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States, 55101
United States, Missouri
The Children's Mercy Hospital & Clinics
Kansas City, Missouri, United States, 64108
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Clinical Research Center of New Jersey
Voorhees, New Jersey, United States, 08043
United States, New York
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
Columbia University Medical Center Dept. of Rehab. & Regenerative Medicine
New York, New York, United States, 10032
United States, North Carolina
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, United States, 28203
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Baylor College of Medicine Texas Children's Hospital
Houston, Texas, United States, 77030
Road Runner Research
San Antonio, Texas, United States, 78258
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Canada, Ontario
Holland Bloorview Kids Rehab
Toronto, Ontario, Canada, M4G 1R8
Hungary
Semmelweise Egyetem- Ortopediai Klinika
Budapest, Hungary, 1113
Debrecen University Clinical Center, Orthopedic Clinic
Debrecen, Hungary, 4032
Italy
Istituto IRCCS G. Gaslini
Genoa, Italy, 16147
Korea, Republic of
Daegu Fatima Hospital
Daegu, Korea, Republic of, 41199
National Health Insurance Service Ilsan Hospital
Goyang-si, Korea, Republic of, 10444
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Philippines
De La Salle University Medical Center
Dasmarinas, Cavite, Philippines, 4114
Philippine Orthopedic Center
Bagong Pag-asa, Quezon City, Philippines, 1100
St. Luke's Medical Center-Quezon City
Bagong Pag-asa, Quezon City, Philippines, 1102
Philippine Children's Medical Center
Bagong Pag-asa, Quezon City, Philippines, 1104
Poland
Uniwersytecki Dzieiecy Szpita
Bialystok, Poland, 15-274
Uni Centrum Kliniczne
Gdansk, Poland, 80-219
Centrum Rehabilitacji Krok po Kroku
Gdansk, Poland, 80-389
Specjal. Gabinet Neurologiczny
Krakow, Poland, 30-359
Centrum Medyczne "POMOC"
Lodz, Poland, 93-271
INTERMED, Lublin
Lublin, Poland, 20-058
CRH ŻAGIEL MED, Lublin
Lublin, Poland, 20-601
Szpital Wojewodzki Nr 2
Rzeszow, Poland, 35-301
Neuro - Dzieci I Mlodziezy Aga
Warsaw, Poland, 02-315
NZOZ Mazowieckie Centrum
Warsaw, Poland, 05-462
Russian Federation
Childrens Republic Hospital
Kazan, Russian Federation, 420138
Smolensk Regional Hospital- Regional Budget State Healthcare institution
Smolensk, Russian Federation, 214018
Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region
Tyumen, Russian Federation, 625039
Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
Chiang Mai, Thailand, 50200
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Thailand, 40002
Turkey
Ankara Diskapi Yildrim Beyazit
Ankara, Turkey, 6110
Kocaeli Üniversitesi
Kocaeli, Turkey, 41380
Selcuk Universitesi
Konya, Turkey, 42250
Sponsors and Collaborators
Allergan
Investigators
Study Director: Rozalina Dimitrova Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01603602     History of Changes
Other Study ID Numbers: 191622-101
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents