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

Allergan Limited0 sites412 target enrollmentJuly 17, 2012

Conditionspper Limb Spasticity.MedDRA version: 15.1Level: PTClassification code 10028335Term: Muscle spasticitySystem Organ Class: 10029205 - Nervous system disorders MedDRA version: 15.1Level: 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: 412
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

July 17, 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 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 the 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 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