Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

BOTOX® Treatment in Pediatric Lower Limb Spasticity

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01603628
First received: May 21, 2012
Last updated: November 21, 2016
Last verified: November 2016

May 21, 2012
November 21, 2016
July 2012
April 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 ] [ 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 ]
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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Severity of Spasticity of the Ankle Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Recruiting
412
May 2017
April 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
Both
2 Years to 16 Years   (Child)
No
Contact: Clinical Trials Registry Team 1-800-347-4500 IR-CTRegistration@allergan.com
United States,   Hungary,   Italy,   Korea, Republic of,   Philippines,   Poland,   Russian Federation,   Thailand,   Turkey
 
NCT01603628
191622-111
Yes
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Not Provided
Allergan
November 2016

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