Childhood Hypertonia of Central Origin: A Trial of Anticholinergic Treatment Effects

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open-label trial of trihexyphenidyl in children with upper extremity dystonia due to cerebral palsy. It is hypothesized that trihexyphenidyl in doses up to 0.75mg/kg/day would be well-tolerated and show significant changes on the Melbourne scale of upper extremity function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborators: Crowley Carter Foundation; Don and Linda Carter Foundation; United Cerebral Palsy Foundation
• Treatments: Cholinergic Antagonists; Trihexyphenidyl

Criteria

Inclusion Criteria:

• Dystonia in the dominant upper extremity

Exclusion Criteria:

• Complete absence of voluntary movement in the affected hands, wrists, and elbows

• Severe weakness in the dominant upper extremity (MRC grade < 4)

• Passive range of motion at the hand, wrist or elbow less than 80% of normal

• Current use of medications for dystonia (anticholinergics, L-dopa, baclofen, diazepam, tizanidine, tetrabenazine, reserpine, and others)

• Changes in the subject's physical therapy regimen for the duration of the 15-week study

• Prior use of trihexyphenidyl or other anticholinergic therapy for dystonia.

• History of surgery on the dominant upper extremity or cervical spine

• Botulinum toxin injection in the dominant upper extremity within the previous 6 months

• Current or prior implantation of an intrathecal baclofen pump, deep brain stimulator, or other device to treat dystonia or spasticity

• Concurrent acute or chronic medical condition (such as frequent seizures, heart disease, or asthma) that could adversely affect motor performance or the safety of testing

• Presence of diurnal fluctuations or other clinical signs and symptoms suggesting an inborn error of metabolism, a family history of dystonia suggesting a genetic dystonia, or dystonia due to injury after the neonatal period (including toxin exposure, trauma, or medication-induced)

• History of allergic or adverse reaction to trihexyphenidyl or other anticholinergic medications

• Current complaint of urinary retention requiring treatment.

• History of glaucoma, or family history of glaucoma with onset before age 40