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

NCT00122044 | Completed Phase 2

• 1 other identifier: CHOCOLATE
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Dystonia

Keywords

childhood; cerebral palsy; dystonia; secondary; trihexyphenidyl; pediatric dystonia

Outcome Measures

Primary Outcomes (1)

• Melbourne assessment of upper extremity function

Secondary Outcomes (5)

• Barry-Albright Dystonia Scale

• Burke-Fahn-Marsden Dystonia Scale

• Pediatric Outcomes Data Collection Instrument

• Pediatric Quality of Life

• Gross Motor Function Measure

Interventions

trihexyphenidyl DRUG

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• United Cerebral Palsy Foundation: collaborator
• University of Southern California: lead
• Don and Linda Carter Foundation: collaborator
• Crowley Carter Foundation: collaborator

Study Sites (7)

University of Alabama School of Medicine

Birmingham, Alabama, 35233, United States

Location

Stanford University

Stanford, California, 94305-5235, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Texas Scottish Rite Hospital for Children

Dallas, Texas, 75219, United States

Location

Related Links

• Information on childhood dystonia and other movement disorders

MeSH Terms

Conditions

Dystonia; Cerebral Palsy; Neoplasm Metastasis

Interventions

Trihexyphenidyl

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Terence D Sanger, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 18, 2005
• First Posted: July 21, 2005
• Study Start: January 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

US (7)