BOTOX® Treatment in Pediatric Lower Limb Spasticity
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2016 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01603628
First received: May 21, 2012
Last updated: September 22, 2016
Last verified: September 2016
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Purpose
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.
| Condition | Intervention | Phase |
|---|---|---|
|
Pediatrics Muscle Spasticity Cerebral Palsy |
Biological: botulinum toxin Type A Drug: Normal Saline (Placebo) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | BOTOX® Treatment in Pediatric Lower 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) Ankle Score Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression (CGI) Of Overall Change by Physician Compared to Baseline Using a 9-Point Scale [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Goal Attainment Score as Assessed by Physician Using a 6-Point Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Change from Baseline in Severity of Spasticity of the Ankle Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 412 |
| 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® 4 U/kg
Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb.
|
Biological: botulinum toxin Type A
Subjects will receive intramuscular injections of botulinum toxin Type A 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb.
Other Name: BOTOX®
|
|
Experimental: BOTOX® 8 U/kg
Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb.
|
Biological: botulinum toxin Type A
Subjects will receive intramuscular injections of botulinum toxin Type A 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb.
Other Name: BOTOX®
|
|
Placebo Comparator: Normal Saline (Placebo)
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the lower limb.
|
Drug: Normal Saline (Placebo)
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the lower limb.
|
Eligibility| Ages Eligible for Study: | 2 Years to 16 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Minimum weight of 10 kg/22 lb
- Cerebral palsy with dynamic muscle contracture /spasticity of the ankle
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
- History of surgical intervention of the lower study leg or planned surgery of any 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 upper 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: NCT01603628
Show 56 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603628
Contacts
| Contact: Clinical Trials Registry Team | 1-800-347-4500 | IR-CTRegistration@allergan.com |
Show 56 Study Locations
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Dawn Drake | Allergan |
More Information
Additional Information:
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01603628 History of Changes |
| Other Study ID Numbers: | 191622-111 |
| Study First Received: | May 21, 2012 |
| Last Updated: | September 22, 2016 |
| Health Authority: | United States: Food and Drug Administration |
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 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 September 23, 2016