BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01603615 |
Recruitment Status
:
Active, not recruiting
First Posted
: May 22, 2012
Last Update Posted
: October 3, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pediatrics Muscle Spasticity Cerebral Palsy Stroke | Biological: botulinum toxin Type A | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 213 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study |
Actual Study Start Date : | October 30, 2012 |
Estimated Primary Completion Date : | August 1, 2018 |
Estimated Study Completion Date : | August 1, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: BOTOX®
Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) into the upper limb muscles and/or lower 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 upper limb muscles and/or lower 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®
|
- Percentage of Patients Reporting at Least One Adverse Event [ Time Frame: 60 Weeks ]

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, Learn About Clinical Studies.
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
- Upper limb spasticity due to cerebral palsy or stroke
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 upper limb 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): NCT01603615

Study Director: | Rozalina Dimitrova | Allergan |
Additional Information:
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT01603615 History of Changes |
Other Study ID Numbers: |
191622-105 |
First Posted: | May 22, 2012 Key Record Dates |
Last Update Posted: | October 3, 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 |