Clinical trial · Interventional
Childhood Hypertonia of Central Origin: A Trial of Anticholinergic Treatment Effects
Childhood Hypertonia of Central Origin: An Open Label Trial of Anticholinergic Treatment Effects
NCT00122044CI-TRIAL-00014683completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dystonia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trihexyphenidyl | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Melbourne assessment of upper extremity function
Secondary outcomes (5)
- measure
- Barry-Albright Dystonia Scale
- measure
- Burke-Fahn-Marsden Dystonia Scale
- measure
- Pediatric Outcomes Data Collection Instrument
- measure
- Pediatric Quality of Life
- measure
- Gross Motor Function Measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.