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NCT00238641 · ClinicalTrials.gov registry record · Phase 1
"does Myobloc™ Improve Functional Hand USE IN Young Children With A Hypertonic Upper Extremity?"
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00238641: Completed Phase 1 study, sponsored by Stanford University.
NCT00238641 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00238641, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
In children with cerebral palsy, stiffness of the arm can develop early and delay or prevent the acquisition of normal hand skills. Improvement in functional use of the hand may therefore be dependent upon early treatment of upper extremity hypertonia. We propose to test a series of injections of Myobloc™ in a non-randomized one-way crossover pilot clinical trial and dose-finding study, with clinical assessments and blinded video evaluations. Ten children age 2-17 years with increased tone at the elbow or wrist will be expected to complete the study. A 1-month baseline evaluation period will be followed by an injection of low-dose Myobloc™ to affected muscle(s) of the arm according to standardized per-kilogram dosing with a maximum of 25U/kg in each affected arm. Three months later, a second injection of up to 50U/kg will be performed in each affected arm. Three months after the second dose, a third dose of up to 100U/kg will be performed in each affected arm. Neurological assessments will be performed at study entry, prior to each injection, and at 1 and 3 months following each injection. Routine physical therapy and non-study medications will be continued during the study.
Interventions
- DRUG Botulinum Toxin type B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2002-01 |
| Est. Completion | 2005-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00238641
The ClinicalTrials.gov registry entry for NCT00238641 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Botulinum Toxin type B is the first listed.
NCT00238641 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00238641 about?
NCT00238641 is a clinical study titled ""does Myobloc™ Improve Functional Hand USE IN Young Children With A Hypertonic Upper Extremity?"". In children with cerebral palsy, stiffness of the arm can develop early and delay or prevent the acquisition of normal hand skills. Improvement in functional use of the hand may therefore be dependent upon early treatment of upper extremity hypertonia. We propose to test a series of injections of My...
What is the current status of trial NCT00238641?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2002-01. Estimated completion is 2005-05.
What interventions are being tested in trial NCT00238641?
The interventions under investigation include: Botulinum Toxin type B (DRUG).
Who is sponsoring clinical trial NCT00238641?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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