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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000084-24 | EudraCT Number |
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This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily McCusker | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ABS Health, LLC | Pasadena | California | 91106 | United States | ||
| Harrison Clinical Management |
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| Label | URL |
|---|---|
| More information | View source |
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Pediatric participants with lower limb spasticity who were previously treated with BOTOX® in study 191622-111 [NCT01603628] and de novo participants received up to 5 BOTOX® treatments in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | BOTOX® | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2014 | Jul 29, 2019 |
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|
| Pomona |
| California |
| 91767 |
| United States |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Associated Neurologists of Southern Connecticut, P.C. | Fairfield | Connecticut | 06824 | United States |
| New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| NW FL Clinical Research Group, LLC | Gulf Breeze | Florida | 32561 | United States |
| Axcess Medical Research, LLC | Loxahatchee Groves | Florida | 33470 | United States |
| Pediatric Neurology, P.A. | Orlando | Florida | 32819 | United States |
| Children's Healthcare of Atlanta Children's Rehabilitation Associates | Atlanta | Georgia | 30342 | United States |
| Shirley Ryan Ability Lab | Chicago | Illinois | 60611 | United States |
| Beaumont Children's Hospital Pediatric Research | Royal Oak | Michigan | 48073 | United States |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Clinical Research Center of New Jersey | Voorhees Township | New Jersey | 08043 | United States |
| NYU Hospital for Joint Diseases | New York | New York | 10003 | United States |
| Columbia University Dept. of Rehab. & Regenerative Medicine | New York | New York | 10032 | United States |
| OnSite Clinical Solutions, LLC | Charlotte | North Carolina | 28203 | United States |
| PMG Research of Charlotte, LLC | Charlotte | North Carolina | 28203 | United States |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Road Runner Research | San Antonio | Texas | 78249 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Semmelweis Egyetem- Ortopédiai Klinika Karolina út 27 | Budapest | 1113 | Hungary |
| Debrecen University Clinical Center, Orthopedic Clinic | Debrecen | 4032 | Hungary |
| Istituto IRCCS G. Salini | Genoa | 16148 | Italy |
| Philippine Orthopedic Center | Quezon City | 1100 | Philippines |
| St. Luke's Medical Center | Quezon City | 1102 | Philippines |
| Philippine Children's Medical Center | Quezon City | 1104 | Philippines |
| Uniwersytecki Dzieciecy Szpita | Bialystok | 15-274 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-219 | Poland |
| Centrum Rehabilitacji Krok po Kroku | Gdansk | 80-389 | Poland |
| Specjalistyczny Gabinet Neurologiczny | Krakow | 30-539 | Poland |
| Centrum Medyczne "POMOC" | Lodz | 93-271 | Poland |
| INTERMED, Lublin | Lublin | 20-058 | Poland |
| CRH ŻAGIEL MED, Lublin | Lublin | 20-601 | Poland |
| Szpital Wojewodzki Nr 2 | Rzeszów | 35-301 | Poland |
| Poradnia Rehab - Neurologiczneij dla Dzieci I Mlodziezy Aga | Warsaw | 02-315 | Poland |
| NZOZ Mazowieckie Centrum | Warsaw | 05-462 | Poland |
| Childrens Republic Hospital | Kazan' | 420138 | Russia |
| Smolensk Regional Hospital- Regional Budget State Healthcare institution | Smolensk | 214018 | Russia |
| Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region | Tyumen | 625039 | Russia |
| Daegu Fatima Hospital | Daegu | 41199 | South Korea |
| National Health Insurance Service Ilsan Hospital | Gyeonggi-do | 10444 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Maharaj Nakorn ChiangMai Hospital | Chiang Mai | 50200 | Thailand |
| Srinagarind Hospital, Khon Kaen University | Khon Kaen | 40002 | Thailand |
| Ankara Diskapi Yildrim Beyazit | Ankara | 6110 | Turkey (Türkiye) |
| Kocaeli Üniversitesi | Kocaeli | 41050 | Turkey (Türkiye) |
| Selçuk Üniversitesi | Konya | 42250 | Turkey (Türkiye) |
| Safety Population (Treated) |
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| Modified Intent-to-treat Population |
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| COMPLETED |
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| NOT COMPLETED |
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Safety population included all treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | BOTOX® | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants | From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks) |
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|
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From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)
Safety Population included all treated participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BOTOX® | 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. | 0 | 367 | 24 | 367 | 145 | 367 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA, Version 21.0 | Systematic Assessment |
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| Entropion | Eye disorders | MedDRA, Version 21.0 | Systematic Assessment |
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| Strabismus | Eye disorders | MedDRA, Version 21.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA, Version 21.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA, Version 21.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA, Version 21.0 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA, Version 21.0 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA, Version 21.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA, Version 21.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA, Version 21.0 | Systematic Assessment |
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| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 21.0 | Systematic Assessment |
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| Febrile convulsion | Nervous system disorders | MedDRA, Version 21.0 | Systematic Assessment |
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| Hemiplegia | Nervous system disorders | MedDRA, Version 21.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA, Version 21.0 | Systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA, Version 21.0 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA, Version 21.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 21.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA, Version 21.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 21.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA, Version 21.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA, Version 21.0 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 2, 2018 | Jul 29, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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| Asian |
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| Hispanic |
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| Other |
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