PediatricsPhase 3NCT01603641
BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
A Phase 3 study testing Botulinum Toxin Type A in people with Pediatrics and Muscle Spasticity, run by Allergan at 56 sites in 9 countries.
Trial summary
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Pediatrics, Muscle Spasticity, Cerebral Palsy
- What is being tested?
- Botulinum Toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 56 sitesin 9 countries
- Study dates
- 5 Nov 2012to 25 Aug 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Minimum weight of 10 kilograms (kg)/22 pounds (lb)
- Cerebral palsy with dynamic muscle contracture of the ankle
Who cannot join
- 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 lower study leg within 1 year, or planned surgery of any limb during the study
Trial locations and contacts
56 sites in 9 countries.
56 sites in 9 countries
United States26 sites
Children's Healthcare of Atlanta Children's Rehabilitation Associates
Atlanta, Georgia, 30342
Children's Hospital Colorado
Aurora, Colorado, 80045
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28203
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28203
Shirley Ryan Ability Lab
Chicago, Illinois, 60611
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, 06824
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, 32561
Baylor College of Medicine Texas Children's Hospital
Houston, Texas, 77030
The Children's Mercy Hospital
Kansas City, Missouri, 64108
Axcess Medical Research, LLC
Loxahatchee Groves, Florida, 33470
Marshfield Clinic
Marshfield, Wisconsin, 54449
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Hospital for Joint Diseases
New York, New York, 10003
Columbia University Dept. of Rehab. & Regenerative Medicine
New York, New York, 10032
Pediatric Neurology, P.A.
Orlando, Florida, 32819
ABS Health, LLC
Pasadena, California, 91106
Harrison Clinical Management
Pomona, California, 91767
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Beaumont Children's Hospital Pediatric Research
Royal Oak, Michigan, 48073
Road Runner Research
San Antonio, Texas, 78249
Rady Children's Hospital San Diego
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63110
New England Institute for Clinical Research
Stamford, Connecticut, 06905
Clinical Research Center of New Jersey
Voorhees Township, New Jersey, 08043
Poland10 sites
Uniwersytecki Dzieciecy Szpita
Bialystok, 15-274
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-219
Centrum Rehabilitacji Krok po Kroku
Gdansk, 80-389
Specjalistyczny Gabinet Neurologiczny
Krakow, 30-539
Centrum Medyczne "POMOC"
Lodz, 93-271
INTERMED, Lublin
Lublin, 20-058
CRH ŻAGIEL MED, Lublin
Lublin, 20-601
Szpital Wojewodzki Nr 2
Rzeszów, 35-301
Poradnia Rehab - Neurologiczneij dla Dzieci I Mlodziezy Aga
Warsaw, 02-315
NZOZ Mazowieckie Centrum
Warsaw, 05-462
South Korea6 sites
Daegu Fatima Hospital
Daegu, 41199
National Health Insurance Service Ilsan Hospital
Gyeonggi-do, 10444
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Philippines3 sites
Philippine Orthopedic Center
Quezon City, 1100
St. Luke's Medical Center
Quezon City, 1102
Philippine Children's Medical Center
Quezon City, 1104
Russia3 sites
Childrens Republic Hospital
Kazan', 420138
Smolensk Regional Hospital- Regional Budget State Healthcare institution
Smolensk, 214018
Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region
Tyumen, 625039
Turkey (Türkiye)3 sites
Ankara Diskapi Yildrim Beyazit
Ankara, 6110
Kocaeli Üniversitesi
Kocaeli, 41050
Selçuk Üniversitesi
Konya, 42250
Hungary2 sites
Semmelweis Egyetem- Ortopédiai Klinika Karolina út 27
Budapest, 1113
Debrecen University Clinical Center, Orthopedic Clinic
Debrecen, 4032
Thailand2 sites
Maharaj Nakorn ChiangMai Hospital
Chiang Mai, 50200
Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002
About this study
Official title: BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.
- Conditions
- Pediatrics, Muscle Spasticity, Cerebral Palsy
- Being tested
- Botulinum Toxin Type A
- Medical subject headings
- Muscle Spasticity, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type ABiological
Also called BOTOX®, OnabotulinumtoxinA
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.
| Study group | Role | What they receive |
|---|---|---|
| BOTOX® | Experimental | Participants received maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into a single lower limb muscles or divided between both lower limb muscles or into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment not to exceed a maximum of 8 unit per kilogram (U/kg) of body weight (not to exceed 300 U) in treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 or 8 U/kg into the lower limb in the previous study or were de novo participants who were not enrolled in the previous study. Receives: Biological: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study start5 Nov 2012
- Primary completion25 Aug 2018
- Study completion25 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PediatricsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emily McCusker, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603641
- Sponsor's protocol ID
- 191622-112
- Other IDs
- 2012-000084-24
- Status last verified
- Jul 2019
- First submitted
- 21 May 2012
- Last updated
- 21 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study
- ClinicalTrials.gov ID
- NCT01603641
- Acronym / sponsor ID
- 191622-112
- Conditions
- Pediatrics, Muscle Spasticity, Cerebral Palsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2012 (actual)
- Primary completion
- 25 Aug 2018 (actual)
- Study completion
- 25 Aug 2018 (actual)
- First posted
- 22 May 2012 (estimated)
- Results
- Posted 21 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOTOX® | Experimental | Biological: Botulinum Toxin Type AParticipants received maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into a single lower limb muscles or divided between both lower limb muscles or into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment not to exceed a maximum of 8 unit per kilogram (U/kg) of body weight (not to exceed 300 U) in treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 or 8 U/kg into the lower limb in the previous study or were de novo participants who were not enrolled in the previous study. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Minimum weight of 10 kilograms (kg)/22 pounds (lb)
- Cerebral palsy with dynamic muscle contracture of the ankle
Key exclusion criteria (4 listed)
- 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 lower study leg within 1 year, or planned surgery of any limb during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AAlso: BOTOX®, OnabotulinumtoxinAParticipants 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. | Biological | BOTOX® |
Primary outcome
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily McCusker study director
Allergan
56 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A in people with Pediatrics and Muscle Spasticity, run by Allergan at 56 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Poland, South Korea, Philippines, Russia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) (time frame: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.