BOTOX® Open-Label Treatment in Pediatric Lower 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:
NCT01603641
First received: May 21, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.


Condition Intervention Phase
Pediatrics
Muscle Spasticity
Cerebral Palsy
Biological: botulinum toxin Type A
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients Reporting at Least One Adverse Event [ Time Frame: 60 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: August 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BOTOX®
Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments. Treatment dosing will be according to investigator judgment not to exceed a maximum of 10 U per kg of body weight (10 U/kg) per treatment.
Biological: botulinum toxin Type A
Subjects will receive intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments. Treatment dosing will be according to investigator judgment not to exceed a maximum of 10 U per kg of body weight (10 U/kg) per treatment.
Other Name: BOTOX®

  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 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 3 months
  • History of surgical intervention of the lower study leg within 1 year, or planned surgery of any 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: NCT01603641

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
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01603641     History of Changes
Other Study ID Numbers: 191622-112
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
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
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 October 29, 2014