Back to resultsBOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
Primary Purpose
Pediatrics, Muscle Spasticity, Cerebral Palsy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Pediatrics
Eligibility Criteria
Inclusion Criteria:
- Minimum weight of 10 Kilograms (kg) / 22 Pounds (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 3 months
- History of surgical intervention of the upper limb within 1 year, or planned surgery of any limb during the study
Sites / Locations
- ABS Health, LLC
- Harrison Clinical Management
- Rady Children's Hospital San Diego
- Children's Hospital Colorado Dept. of PM&R
- Associated Neurologists of Southern Connecticut, P.C.
- New England Center for Clinical Research
- NW FL Clinical Research Group, LLC
- Axcess Medical Research, LLC
- Pediatric Neurology, PA
- Children's Healthcare of Atlanta Children's Rehabilitation Associates
- Gillette Children's Specialty Healthcare
- The Children's Mercy Hospital & Clinics
- Washington University School of Medicine
- Clinical Research Center of New Jersey
- NYU Hospital for Joint Diseases
- Columbia University Pediatric Physical Medicine & Rehabilitation, Dept. of Rehabilitation & Regenerative Medicine Harkness
- OnSite Clinical Solutions, LLC
- PMG Research of Charlotte, LLC
- Vanderbilt University Medical Center
- University of Texas Southwestern Medical Center
- Baylor College of Medicine Texas Children's Hospital
- Road Runner Research
- Seattle Children's Hospital
- Marshfield Clinic
- Holland Bloorview Kids Rehab
- Debrecen University Clinical Center, Orthopedic Clinic
- Daegu Fatima Hospital
- National Health Insurance Service Ilsan Hospital
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Samsung Medical Center
- De La Salle Health Sciences Institute
- Philippine Children's Medical Center
- Uni Centrum Kliniczne
- Specjal. Gabinet Neurologiczny
- Centrum Medyczne "POMOC"
- INTERMED, Lublin
- CRH ŻAGIEL MED, Lublin
- Centrum Profilatyki I Terapii
- NZOZ Mazowieckie Centrum
- Childrens Republic Hospital
- Smolensk Regional Hospital- Regional Budget State Healthcare institution
- Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region
- Siriraj Hospital Dept of Rehabilitation Medicine, Faculty of Medicine
- Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
- Srinagarind Hospital, Khon Kaen University
- Kocaeli Üniversitesi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BOTOX®
Arm Description
Participants received a maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into upper limb and/or lower limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment, de novo participants received at least 6 U/kg of body weight or a maximum of 8 U/kg of body weight (not to exceed 300 U). Rollover participants received up to a maximum of 8 U/kg of body weight (not to exceed 300 U) for treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Rolled over participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 or 6 U/kg into upper limb in previous study or were de novo participants who were not enrolled in previous study.
Outcomes
Primary Outcome Measures
Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period. Safety population included all treated participants.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01603615
Brief Title
BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
Official Title
BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 30, 2012 (Actual)
Primary Completion Date
September 3, 2018 (Actual)
Study Completion Date
September 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatrics, Muscle Spasticity, Cerebral Palsy, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOTOX®
Arm Type
Experimental
Arm Description
Participants received a maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into upper limb and/or lower limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment, de novo participants received at least 6 U/kg of body weight or a maximum of 8 U/kg of body weight (not to exceed 300 U). Rollover participants received up to a maximum of 8 U/kg of body weight (not to exceed 300 U) for treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Rolled over participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 or 6 U/kg into upper limb in previous study or were de novo participants who were not enrolled in previous study.
Intervention Type
Biological
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
BOTOX® OnabotulinumtoxinA
Intervention Description
Participants received intramuscular injections of botulinum Toxin Type A in the upper and/or lower limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE)
Description
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period. Safety population included all treated participants.
Time Frame
From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Minimum weight of 10 Kilograms (kg) / 22 Pounds (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 3 months
History of surgical intervention of the upper limb within 1 year, or planned surgery of any limb during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily McCusker
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
ABS Health, LLC
City
Pasadena
State/Province
California
ZIP/Postal Code
91106
Country
United States
Facility Name
Harrison Clinical Management
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Rady Children's Hospital San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Children's Hospital Colorado Dept. of PM&R
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Associated Neurologists of Southern Connecticut, P.C.
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
New England Center for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
NW FL Clinical Research Group, LLC
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Axcess Medical Research, LLC
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Pediatric Neurology, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32891
Country
United States
Facility Name
Children's Healthcare of Atlanta Children's Rehabilitation Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Gillette Children's Specialty Healthcare
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
The Children's Mercy Hospital & Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Clinical Research Center of New Jersey
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
NYU Hospital for Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia University Pediatric Physical Medicine & Rehabilitation, Dept. of Rehabilitation & Regenerative Medicine Harkness
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
OnSite Clinical Solutions, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
PMG Research of Charlotte, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Road Runner Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Holland Bloorview Kids Rehab
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada
Facility Name
Debrecen University Clinical Center, Orthopedic Clinic
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Daegu Fatima Hospital
City
Daegu
ZIP/Postal Code
41199
Country
Korea, Republic of
Facility Name
National Health Insurance Service Ilsan Hospital
City
Gyeonggi-do
ZIP/Postal Code
10444
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
De La Salle Health Sciences Institute
City
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Philippine Children's Medical Center
City
Quezon City
ZIP/Postal Code
1104
Country
Philippines
Facility Name
Uni Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Specjal. Gabinet Neurologiczny
City
Krakow
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Centrum Medyczne "POMOC"
City
Lodz
ZIP/Postal Code
93-271
Country
Poland
Facility Name
INTERMED, Lublin
City
Lublin
ZIP/Postal Code
20-058
Country
Poland
Facility Name
CRH ŻAGIEL MED, Lublin
City
Lublin
ZIP/Postal Code
20-601
Country
Poland
Facility Name
Centrum Profilatyki I Terapii
City
Warsaw
ZIP/Postal Code
02-383
Country
Poland
Facility Name
NZOZ Mazowieckie Centrum
City
Warsaw
ZIP/Postal Code
05-462
Country
Poland
Facility Name
Childrens Republic Hospital
City
Kazan
ZIP/Postal Code
420138
Country
Russian Federation
Facility Name
Smolensk Regional Hospital- Regional Budget State Healthcare institution
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region
City
Tyumen
ZIP/Postal Code
625039
Country
Russian Federation
Facility Name
Siriraj Hospital Dept of Rehabilitation Medicine, Faculty of Medicine
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Kocaeli Üniversitesi
City
Kocaeli
ZIP/Postal Code
41050
Country
Turkey
12. IPD Sharing Statement
Links:
URL
http://www.allerganclinicaltrials.com
Description
More information
Learn more about this trial
BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
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