BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01603641
First received: May 21, 2012
Last updated: October 20, 2014
Last verified: October 2014
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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 |
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: | August 2012 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | July 2017 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603641
Contacts
| Contact: Allergan Inc. | clinicaltrials@allergan.com |
Locations
| United States, Connecticut | |
| Recruiting | |
| Fairfield, Connecticut, United States | |
| Hungary | |
| Recruiting | |
| Debrecen, Hungary | |
| Italy | |
| Withdrawn | |
| Conegliano, Italy | |
| Withdrawn | |
| Genoa, Italy | |
| Korea, Republic of | |
| Recruiting | |
| Seoul, Korea, Republic of | |
| Poland | |
| Recruiting | |
| Wiązowna, Poland | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
More Information
Additional Information:
No publications provided
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01603641 History of Changes |
| Other Study ID Numbers: | 191622-112 |
| Study First Received: | May 21, 2012 |
| Last Updated: | October 20, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Muscle Spasticity Muscle Hypertonia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Signs and Symptoms Botulinum Toxins |
Botulinum Toxins, Type A Anti-Dyskinesia Agents Central Nervous System Agents Neuromuscular Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015