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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). 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 |
What the finished NCT00238641 record still lists
NCT00238641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Botulinum Toxin type B is the first listed.
NCT00238641 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00238641's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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