BOTOX® Open-Label 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:
NCT01603641
First received: May 21, 2012
Last updated: September 22, 2016
Last verified: September 2016
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Purpose
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.
| Condition | Intervention | Phase |
|---|---|---|
|
Pediatrics Muscle Spasticity Cerebral Palsy |
Biological: botulinum toxin Type A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label 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:
- Percentage of Patients Reporting at Least One Adverse Event [ Time Frame: 60 Weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 350 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | August 2018 |
| Estimated Primary Completion Date: | August 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BOTOX®
Subjects will receive intramuscular injections of BOTOX® (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. Treatment dosing will be according to investigator judgment not to exceed a maximum of 10 U per kg of body weight (10 U/kg) per treatment.
|
Biological: botulinum toxin Type A
Subjects will receive 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. Treatment dosing will be according to investigator judgment not to exceed a maximum of 10 U per kg of body weight (10 U/kg) per treatment.
Other Name: BOTOX®
|
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 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 3 months
- History of surgical intervention of the lower study leg within 1 year, or planned surgery of any 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: NCT01603641
Show 54 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603641
Contacts
| Contact: Clinical Trials Registry Team | 1-800-347-4500 | IR-CTRegistration@allergan.com |
Show 54 Study Locations
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Dawn Drake | Allergan |
More Information
Additional Information:
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01603641 History of Changes |
| Other Study ID Numbers: | 191622-112 |
| Study First Received: | May 21, 2012 |
| Last Updated: | September 22, 2016 |
| Health Authority: | United States: Food and Drug Administration |
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 September 30, 2016