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BOTOX® Treatment in Pediatric Lower Limb Spasticity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01603628
First Posted: May 22, 2012
Last Update Posted: September 6, 2017
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.
Information provided by (Responsible Party):
Allergan
May 21, 2012
May 22, 2012
September 6, 2017
September 11, 2012
June 28, 2017   (Final data collection date for primary outcome measure)
  • Change from Baseline in Modified Ashworth Scale - Bohannon (MAS-B) Ankle Score Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ]
  • Clinical Global Impression (CGI) Of Overall Change by Physician Compared to Baseline Using a 9-Point Scale [ Time Frame: Baseline, 6 Weeks ]
Same as current
Complete list of historical versions of study NCT01603628 on ClinicalTrials.gov Archive Site
  • Goal Attainment Score as Assessed by Physician Using a 6-Point Scale [ Time Frame: Week 12 ]
  • Change from Baseline in Severity of Spasticity of the Ankle Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline, 6 Weeks ]
Same as current
Not Provided
Not Provided
 
BOTOX® Treatment in Pediatric Lower Limb Spasticity
BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pediatrics
  • Muscle Spasticity
  • Cerebral Palsy
  • Biological: botulinum toxin Type A
    Subjects will receive intramuscular injections of botulinum toxin Type A 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb.
    Other Name: BOTOX®
  • Biological: botulinum toxin Type A
    Subjects will receive intramuscular injections of botulinum toxin Type A 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb.
    Other Name: BOTOX®
  • Drug: Normal Saline (Placebo)
    Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the lower limb.
  • Experimental: BOTOX® 4 U/kg
    Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb.
    Intervention: Biological: botulinum toxin Type A
  • Experimental: BOTOX® 8 U/kg
    Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb.
    Intervention: Biological: botulinum toxin Type A
  • Placebo Comparator: Normal Saline (Placebo)
    Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the lower limb.
    Intervention: Drug: Normal Saline (Placebo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
384
June 28, 2017
June 28, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Minimum weight of 10 kg/22 lb
  • Cerebral palsy with dynamic muscle contracture /spasticity 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 6 months
  • History of surgical intervention of the lower study leg or planned surgery of any 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 upper limb during the study
Sexes Eligible for Study: All
2 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Hungary,   Italy,   Korea, Republic of,   Philippines,   Poland,   Russian Federation,   Thailand,   Turkey,   United States
 
 
NCT01603628
191622-111
Yes
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Rozalina Dimitrova Allergan
Allergan
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP