BOTOX® Treatment in Pediatric Lower Limb Spasticity

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01603628
First received: May 21, 2012
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.


Condition Intervention Phase
Pediatrics
Muscle Spasticity
Cerebral Palsy
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) 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 412
Study Start Date: July 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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®
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.
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®
Placebo Comparator: Normal Saline (Placebo)
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the lower limb.
Drug: Normal Saline (Placebo)
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the lower 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
  • 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
  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: NCT01603628

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
United States, Connecticut
Recruiting
Fairfield, Connecticut, United States
Hungary
Recruiting
Debrecen, Hungary
Italy
Withdrawn
Conegliano, Italy
Recruiting
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:
No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01603628     History of Changes
Other Study ID Numbers: 191622-111
Study First Received: May 21, 2012
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Muscle Spasticity
Cerebral Palsy
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, 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 September 22, 2014