BOTOX® Open-Label Treatment in Pediatric Upper 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:
NCT01603615
First received: May 21, 2012
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Pediatrics
Muscle Spasticity
Cerebral Palsy
Stroke
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: September 2016
Estimated Primary Completion Date: September 2016 (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 upper limb muscles and/or lower 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 upper limb muscles and/or lower 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
  • 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 3 months
  • History of surgical intervention of the upper limb 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: NCT01603615

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

Additional Information:
No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01603615     History of Changes
Other Study ID Numbers: 191622-105
Study First Received: May 21, 2012
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Spasticity
Stroke
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
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
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 July 26, 2014