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Trial record 3 of 8 for:    BOTOX; pediatric | Interventional Studies | Muscle Spasticity | Child | Phase 3

BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity

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ClinicalTrials.gov Identifier: NCT01603615
Recruitment Status : Completed
First Posted : May 22, 2012
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.

Condition or disease Intervention/treatment Phase
Pediatrics Muscle Spasticity Cerebral Palsy Stroke Biological: Botulinum Toxin Type A Phase 3

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Study Type : Interventional
Actual Enrollment : 220 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study
Actual Study Start Date : October 30, 2012
Actual Primary Completion Date : September 3, 2018
Actual Study Completion Date : September 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: BOTOX®
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.
Biological: Botulinum Toxin Type A
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.
Other Name: BOTOX® OnabotulinumtoxinA




Primary Outcome Measures :
  1. 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. Safety population included all treated participants.



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01603615


  Show 48 Study Locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Emily McCusker Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] August 1, 2016
Statistical Analysis Plan  [PDF] January 14, 2019


Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01603615     History of Changes
Other Study ID Numbers: 191622-105
2012-000043-27 ( EudraCT Number )
First Posted: May 22, 2012    Key Record Dates
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Muscle Hypertonia
abobotulinumtoxinA
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
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