BOTOX® Treatment in Pediatric Upper Limb Spasticity

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2014 by Allergan

Sponsor:

Information provided by (Responsible Party):

Allergan

ClinicalTrials.gov Identifier:

NCT01603602

First received: May 21, 2012

Last updated: October 20, 2014

Last verified: October 2014

History of Changes

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:

MedlinePlus related topics: Botox

Drug Information available for: OnabotulinumtoxinA

Genetic and Rare Diseases Information Center resources: Cerebral Palsy

U.S. FDA Resources

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

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: NCT01603602

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
Russian Federation
	Recruiting
Kazan, Russian Federation
Turkey
	Recruiting
Kocaeli, Turkey

Sponsors and Collaborators

Allergan

Investigators


Study Director:	Medical Director	Allergan

More Information

Additional Information:

More information This link exits the ClinicalTrials.gov site

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:	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

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