BOTOX® Treatment in Pediatric Upper Limb Spasticity
This study has been completed.
Sponsor:
Allergan
ClinicalTrials.gov Identifier:
NCT01603602
First Posted: May 22, 2012
Last Update Posted: September 6, 2017
Information provided by (Responsible Party):
Allergan
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Purpose
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.
| Condition | Intervention | Phase |
|---|---|---|
| Pediatrics Muscle Spasticity Cerebral Palsy Stroke | Biological: botulinum toxin Type A Drug: Normal Saline (Placebo) | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | BOTOX® Treatment in Pediatric Upper Limb Spasticity: Double-blind Study |
Resource links provided by NLM:
MedlinePlus related topics:
Botox
Drug Information available for:
OnabotulinumtoxinA
U.S. FDA Resources
Further study details as provided by Allergan:
Primary Outcome Measures:
- Change from Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ]
- Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale [ Time Frame: Baseline, 6 Weeks ]
Secondary Outcome Measures:
- Change from Baseline in MAS-B Score of the Finger Flexor Muscle Group Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ]
- Goal Attainment Score as Assessed by Physician Using a 6-Point Scale [ Time Frame: Week 12 ]
- Change from Baseline in Severity of Spasticity of the Principal Muscle Group Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline, 6 Weeks ]
| Enrollment: | 235 |
| Study Start Date: | July 12, 2012 |
| Study Completion Date: | July 6, 2017 |
| Primary Completion Date: | June 29, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BOTOX® 3 U/kg
Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U per kg of body weight (3 U/kg) into specified muscles of the upper limb.
|
Biological: botulinum toxin Type A
Subjects will receive intramuscular injections of botulinum toxin Type A 3 U per kg of body weight (3 U/kg) into specified muscles of the upper limb.
Other Name: BOTOX®
|
|
Experimental: BOTOX® 6 U/kg
Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb.
|
Biological: botulinum toxin Type A
Subjects will receive intramuscular injections of botulinum toxin Type A 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb.
Other Name: BOTOX®
|
|
Placebo Comparator: Placebo
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the upper limb.
|
Drug: Normal Saline (Placebo)
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the upper limb.
|
Eligibility
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| Ages Eligible for Study: | 2 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Minimum weight of 10 kg/22 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 6 months
- Previous surgical treatment of the study limb (except tendon lengthening), or planned surgery of the study limb during the study
- Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected lower limb during the study
Contacts and Locations
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): NCT01603602
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Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Rozalina Dimitrova | Allergan |
More Information
Additional Information:
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01603602 History of Changes |
| Other Study ID Numbers: |
191622-101 |
| First Submitted: | May 21, 2012 |
| First Posted: | May 22, 2012 |
| Last Update Posted: | September 6, 2017 |
| Last Verified: | September 2017 |
Additional relevant MeSH terms:
|
Cerebral Palsy Muscle Spasticity Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations Signs and Symptoms |
Botulinum Toxins onabotulinumtoxinA Botulinum Toxins, Type A abobotulinumtoxinA 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 |