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Trial record 14 of 87 for:
Recruiting, Not yet recruiting, Available Studies | "Muscle Spasticity"
BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
This study is currently recruiting participants.
Verified April 2017 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01603641
First received: May 21, 2012
Last updated: April 4, 2017
Last verified: April 2017
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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: | Intervention Model: Single Group Assignment Masking: None (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 ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01603641
Show 60 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 60 Study Locations
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | 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: | April 4, 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 |
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 |
ClinicalTrials.gov processed this record on August 23, 2017