BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study

Allergan Limited0 sites220 target enrollmentJuly 1, 2013

Conditionspper limb spasticity MedDRA version: 16.0Level: PTClassification code 10028335Term: Muscle spasticitySystem Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.0Level: LLTClassification code 10048970Term: Arm spasticitySystem Organ Class: 10029205 - Nervous system disorders Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

DrugsBOTOX®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: pper limb spasticity
Sponsor: Allergan Limited
Enrollment: 220
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 1, 2013

End Date

September 3, 2018

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Allergan Limited

Eligibility Criteria

Inclusion Criteria

•Rollover patients:
•Eligible patients who successfully completed Allergan Study 191622\-101 without major protocol deviations (eg, noncompliance to protocol\-required procedures) and who, in the investigator’s clinical judgment, did not experience an adverse event that may indicate an unacceptable safety risk for additional BOTOX treatments
•Stable medical condition in the investigator’s opinion
•Written informed consent has been obtained from parent/legally authorized representative
•Written minor assent has been obtained in accordance with local laws and institutional review board (IRB)/independent ethics committee (IEC) requirements
•Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information for United States \[US] sites and written Data Protection consent for European Union \[EU] sites)
•Negative urine pregnancy test at day 1 visit (for females of childbearing potential, defined as females post menarche)
•De novo patients:
•Male or female, 2 to 16 years and 11 months of age (prior to 17th birthday) at the day 1 visit
•Minimum weight of 10 kg at the screening and day 1visits

Exclusion Criteria

•Any uncontrolled clinically significant medical condition other than the condition under study
•Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A Purified Neurotoxin Complex, including diagnosed muscular dystrophy (eg, Duchenne’s muscular dystrophy), myasthenia gravis, Eaton\-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease that might interfere with neuromuscular function
•Fixed contracture of the principal muscle group (elbow or wrist) for the study limb
•Uncontrolled epilepsy defined as more than 1 generalized seizure per month within 3 months prior to the day 1 visit or history of prolonged seizures or repetitive seizure activity requiring administration of a rescue benzodiazepine (oral, rectal, etc) more than once a month, seizures lasting more than 10 minutes, status epilepticus, or epilepsy with autonomic involvement within 9 months prior to the day 1 visit
•Patients with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, uncontrolled asthma, or compromised respiratory function within 12 months prior to the day 1 visit that may indicate a vulnerable respiratory state per investigator’s clinical judgment
•Patients with presence or history (within 12 months prior to the day 1 visit) of aspiration or a condition(s) that, in the investigator’s opinion, may put the patient at an increased risk for aspiration (eg, significant drooling, chronic dysphagia \[difficulty swallowing] requiring changes in diet, or clinically significant gastroesophageal reflux disease)
•Patients previously exposed to botulinum toxin therapy of any serotype who have a history of allergy or sensitivity to the toxin or its components or other significant adverse experiences that, in the investigator’s opinion, may put the patient at an unacceptable risk
•Botulinum toxin therapy of any serotype for any condition within 3 months prior to the day 1 visit (de novo patients only)
•History of treatment with phenol or alcohol block in the study upper limb within 6 months prior to the day 1 visit (de novo patients only) or planned treatment with phenol or alcohol block in the study upper limb during the study
•History of or planned treatment during the study with selective dorsal rhizotomy or deep brain stimulation