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BOTOX® Treatment in Pediatric Upper Limb Spasticity
This study is currently recruiting participants.
Verified April 2017 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01603602
First received: May 21, 2012
Last updated: April 3, 2017
Last verified: April 2017
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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: 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 ]
| Estimated Enrollment: | 224 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | April 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| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603602
Show 60 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603602
Contacts
| Contact: Clinical Trials Registry Team | 1-800-347-4500 | IR-CTRegistration@allergan.com |
Show 60 Study Locations
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
More Information
Additional Information:
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01603602 History of Changes |
| Other Study ID Numbers: |
191622-101 |
| Study First Received: | May 21, 2012 |
| Last Updated: | April 3, 2017 |
Additional relevant MeSH terms:
|
Muscle Spasticity Cerebral Palsy 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 onabotulinumtoxinA |
Botulinum Toxins, Type A abobotulinumtoxinA incobotulinumtoxinA Botulinum Toxins 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 |
ClinicalTrials.gov processed this record on June 28, 2017