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

Completed · Phase 2

Conditions studied: Dystonia

In brief

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.

Key facts

Study ID

NCT00122044

Run by

University of Southern California

People needed

35

Starts

2003-01-01

Expected to finish

2004-12-01

Last updated by the study team

2014-05-23

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Dystonia in the dominant upper extremity

You may not qualify if…

• 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

Where it is running

• University of Alabama School of Medicine — Birmingham, Alabama, United States
• Stanford University — Stanford, California, United States
• Rehabilitation Institute of Chicago — Chicago, Illinois, United States
• Kennedy Krieger Institute — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Texas Scottish Rite Hospital for Children — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.