Stroke Clinical Trial
Official title:
BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study
Verified date | July 2019 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.
Status | Completed |
Enrollment | 220 |
Est. completion date | September 3, 2018 |
Est. primary completion date | September 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Holland Bloorview Kids Rehab | Toronto | Ontario |
Hungary | Debrecen University Clinical Center, Orthopedic Clinic | Debrecen | |
Korea, Republic of | Daegu Fatima Hospital | Daegu | |
Korea, Republic of | National Health Insurance Service Ilsan Hospital | Gyeonggi-do | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
Philippines | De La Salle Health Sciences Institute | Cavite | |
Philippines | Philippine Children's Medical Center | Quezon City | |
Poland | Uni Centrum Kliniczne | Gdansk | |
Poland | Specjal. Gabinet Neurologiczny | Krakow | |
Poland | Centrum Medyczne "POMOC" | Lodz | |
Poland | CRH ZAGIEL MED, Lublin | Lublin | |
Poland | INTERMED, Lublin | Lublin | |
Poland | Centrum Profilatyki I Terapii | Warsaw | |
Poland | NZOZ Mazowieckie Centrum | Warsaw | |
Russian Federation | Childrens Republic Hospital | Kazan | |
Russian Federation | Smolensk Regional Hospital- Regional Budget State Healthcare institution | Smolensk | |
Russian Federation | Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region | Tyumen | |
Thailand | Siriraj Hospital Dept of Rehabilitation Medicine, Faculty of Medicine | Bangkok | |
Thailand | Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University | Chiang Mai | |
Thailand | Srinagarind Hospital, Khon Kaen University | Khon Kaen | |
Turkey | Kocaeli Üniversitesi | Kocaeli | |
United States | Children's Healthcare of Atlanta Children's Rehabilitation Associates | Atlanta | Georgia |
United States | Children's Hospital Colorado Dept. of PM&R | Aurora | Colorado |
United States | OnSite Clinical Solutions, LLC | Charlotte | North Carolina |
United States | PMG Research of Charlotte, LLC | Charlotte | North Carolina |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Associated Neurologists of Southern Connecticut, P.C. | Fairfield | Connecticut |
United States | NW FL Clinical Research Group, LLC | Gulf Breeze | Florida |
United States | Baylor College of Medicine Texas Children's Hospital | Houston | Texas |
United States | The Children's Mercy Hospital & Clinics | Kansas City | Missouri |
United States | Axcess Medical Research, LLC | Loxahatchee Groves | Florida |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Columbia University Pediatric Physical Medicine & Rehabilitation, Dept. of Rehabilitation & Regenerative Medicine Harkness | New York | New York |
United States | NYU Hospital for Joint Diseases | New York | New York |
United States | Pediatric Neurology, PA | Orlando | Florida |
United States | ABS Health, LLC | Pasadena | California |
United States | Harrison Clinical Management | Pomona | California |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Gillette Children's Specialty Healthcare | Saint Paul | Minnesota |
United States | Road Runner Research | San Antonio | Texas |
United States | Rady Children's Hospital San Diego | San Diego | California |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | New England Center for Clinical Research | Stamford | Connecticut |
United States | Clinical Research Center of New Jersey | Voorhees | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States, Canada, Hungary, Korea, Republic of, Philippines, Poland, Russian Federation, Thailand, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks) |
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