BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
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ClinicalTrials.gov Identifier: NCT01603641 |
Recruitment Status
:
Active, not recruiting
First Posted
: May 22, 2012
Last Update Posted
: October 9, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pediatrics Muscle Spasticity Cerebral Palsy | Biological: botulinum toxin Type A | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 350 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study |
Actual Study Start Date : | November 30, 2012 |
Estimated Primary Completion Date : | August 31, 2018 |
Estimated Study Completion Date : | August 31, 2018 |

Arm | Intervention/treatment |
---|---|
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.
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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®
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- Percentage of Patients Reporting at Least One Adverse Event [ Time Frame: 60 Weeks ]

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Ages Eligible for Study: | 2 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603641

Study Director: | Rozalina Dimitrova | Allergan |
Additional Information:
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT01603641 History of Changes |
Other Study ID Numbers: |
191622-112 |
First Posted: | May 22, 2012 Key Record Dates |
Last Update Posted: | October 9, 2017 |
Last Verified: | October 2017 |
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 |
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 |