BOTOX® Treatment in Pediatric Upper Limb Spasticity
This study is currently recruiting participants.
Verified May 2013 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01603602
First received: May 21, 2012
Last updated: May 17, 2013
Last verified: May 2013
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Purpose
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.
| Condition | Intervention | Phase |
|---|---|---|
|
Pediatrics Muscle Spasticity Cerebral Palsy Stroke |
Biological: botulinum toxin Type A Drug: Normal Saline (Placebo) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Allergan:
Primary Outcome Measures:
- Change from Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from Baseline in MAS-B Score of the Finger Flexor Muscle Group Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]
- Goal Attainment Score as Assessed by Physician Using a 6-Point Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Change from Baseline in Severity of Spasticity of the Principal Muscle Group Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 412 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BOTOX® 3 U/kg
Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U per kg of body weight (3 U/kg) into specified muscles of the upper limb.
|
Biological: botulinum toxin Type A
Subjects will receive intramuscular injections of botulinum toxin Type A 3 U per kg of body weight (3 U/kg) into specified muscles of the upper limb.
Other Name: BOTOX®
|
|
Experimental: BOTOX® 6 U/kg
Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb.
|
Biological: botulinum toxin Type A
Subjects will receive intramuscular injections of botulinum toxin Type A 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb.
Other Name: BOTOX®
|
|
Placebo Comparator: Placebo
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the upper limb.
|
Drug: Normal Saline (Placebo)
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the upper limb.
|
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
- 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 6 months
- Previous surgical treatment of the study limb (except tendon lengthening), or planned surgery of the study limb during the study
- Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected lower limb during the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603602
Contacts
| Contact: Allergan Inc. | clinicaltrials@allergan.com |
Locations
| United States, Connecticut | |
| Recruiting | |
| Fairfield, Connecticut, United States | |
| Hungary | |
| Recruiting | |
| Debrecen, Hungary | |
| 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: | NCT01603602 History of Changes |
| Other Study ID Numbers: | 191622-101 |
| Study First Received: | May 21, 2012 |
| Last Updated: | May 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cerebral Palsy Muscle Spasticity Stroke 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 |
Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013