BOTOX® Treatment in Pediatric Upper Limb Spasticity: Double-blind Study

Allergan Limited0 sites224 target enrollmentOctober 30, 2012

DrugsBOTOX®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Allergan Limited
Enrollment: 224
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 30, 2012

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Allergan Limited

Eligibility Criteria

Inclusion Criteria

•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 1 visits
•Upper limb monoplegic, hemiplegic, or triplegic spasticity (spasticity confirmed by Hypertonia Assessment Tool \[HAT]) with single\-arm sparing (only 1 arm requiring botulinum toxin treatment for spasticity during the study) resulting from cerebral palsy, or post\-stroke with the stroke onset prior to age 2 and at least 12 months prior to the day 1 visit
•Patient’s spasticity meets at least one of the conditions below in the study limb at the screening and day 1 visits:
•o Elbow flexor tone of 2 or greater as measured by the MAS\-B AND elbow flexor muscle contracture of no more than 30 degrees, and/or
•o Wrist flexor tone of 2 or greater with finger flexor tone of 1\+ or greater as measured by the MAS\-B
•AND at least neutral position for wrist with fingers at maximum extension
•Gross Motor Function Classification System Expanded and Revised (GMFCS\-E\&R) level I to IV at the screening visit
•Manual Ability Classification System (MACS) level I to IV at the screening visit
•Patients who are on anti\-spastic medications or muscle relaxants (eg, oral baclofen, tizanidine, dantrolene, scopolamine \[oral or patch], vigabatrin, or benzodiazepine therapy) must be on a stable dose and regimen for at least 30 days prior to the day 1 visit

Exclusion Criteria

•\- Any uncontrolled clinically significant medical condition other than the one 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 in any month within the 3 months prior to the day 1 visit or history of any of the following within 9 months prior to the day 1 visit: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.
•\- Patients with presence or history of any of the following within 12 months prior to the day 1 visit that may indicate a vulnerable respiratory state per the investigator’s clinical judgment: aspiration pneumonia, recurrent lower respiratory tract infections, uncontrolled asthma, or compromised respiratory function.
•\- 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 6 months prior to the day 1 visit
•\- History of treatment with phenol or alcohol block in the study limb within 12 months prior to the day 1 visit or planned treatment with phenol or alcohol block in any limb(s) during the study
•\- History of or planned treatment during the study with selective dorsal rhizotomy or deep brain stimulation