Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00122044
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : May 23, 2014
Sponsor:
Collaborators:
United Cerebral Palsy Foundation
Don and Linda Carter Foundation
Crowley Carter Foundation
Information provided by (Responsible Party):
Terence Sanger, University of Southern California

Tracking Information
First Submitted Date  ICMJE July 18, 2005
First Posted Date  ICMJE July 21, 2005
Last Update Posted Date May 23, 2014
Study Start Date  ICMJE January 2003
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2005)
Melbourne assessment of upper extremity function
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2005)
  • Barry-Albright Dystonia Scale
  • Burke-Fahn-Marsden Dystonia Scale
  • Pediatric Outcomes Data Collection Instrument
  • Pediatric Quality of Life
  • Gross Motor Function Measure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Childhood Hypertonia of Central Origin: A Trial of Anticholinergic Treatment Effects
Official Title  ICMJE Childhood Hypertonia of Central Origin: An Open Label Trial of Anticholinergic Treatment Effects
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.
Detailed Description

BACKGROUND: Although trihexyphenidyl has been used to treat both primary and secondary dystonia in children, previous studies have not investigated efficacy in secondary dystonia. We describe the results of a prospective, open-label, multi-center trial of high-dose trihexyphenidyl in children with secondary dystonia of the arms due to cerebral palsy.

METHODS: Twenty-six children age 4-15 years with cerebral palsy and dystonia that impairs function of the dominant upper extremity were enrolled. All children were given trihexyphenidyl at increasing doses over 9 weeks up to 0.75mg/kg/day. Trihexyphenidyl was subsequently tapered over 5 weeks. Visits occurred at baseline, 9 weeks, and 15 weeks. The primary outcome measure was the Melbourne assessment of upper extremity function, tested in the dominant arm.

RESULTS: Three children withdrew due to non-serious adverse events (chorea, drug rash, hyperactivity). 3 children reduced dosage due to non-serious adverse events. The 23 children who completed the study showed a significant improvement in arm function at 15 weeks (p=0.045) but not at 9 weeks. Post-hoc analysis showed that a subgroup (N=10) with hyperkinetic dystonia worsened at 9 weeks (p=0.04) but subsequently returned to baseline following taper of the medicine.

CONCLUSIONS: Trihexyphenidyl appears to be safe and effective for treatment of arm dystonia in children with cerebral palsy. Children with hyperkinetic dystonia may worsen. A larger randomized prospective trial is needed to confirm these results.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dystonia
Intervention  ICMJE Drug: trihexyphenidyl
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 20, 2005)
35
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2004
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00122044
Other Study ID Numbers  ICMJE CHOCOLATE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Terence Sanger, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE
  • United Cerebral Palsy Foundation
  • Don and Linda Carter Foundation
  • Crowley Carter Foundation
Investigators  ICMJE
Principal Investigator: Terence D Sanger, MD, PhD Stanford University
PRS Account University of Southern California
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP