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NCT02903823 · ClinicalTrials.gov registry record · Phase 4
Intrathecal (IT) Baclofen Drug Distribution
A Phase 4 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
NCT02903823: Completed Phase 4 study, sponsored by Vanderbilt University.
NCT02903823 is a Phase 4 study that has completed, run by Vanderbilt University. The registered enrollment target is 27 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02903823, a Phase 4 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
Study Summary
The goal of this pilot study to determine whether there is a significant therapeutic advantage to place the ITB catheter within the cervical, thoracic or lumbar region of the spine. It is also a goal of this pilot study to determine whether the origin of spasticity influences the effect of Lioresal Intrathecal (baclofen injection) on ITB catheters located in the cervical, thoracic or lumbar regions of the spine. The investigators propose to study the impact of catheter location on the reduction in spasticity within a group of patients who are scheduled for ITB trial.
Primary Outcome
The Modified Ashworth Scale (MAS) is a 6-point scale (Standard MAS scale values: "0, 1, 1.5, 2, 3, or 4") used to evaluate spasticity based on grading muscle tone by moving joints. The MAS scores in this cohort are measured in biceps, triceps and forearm flexor muscles in upper extremities; and quadriceps, hamstrings and gastrocnemius muscles in lower extremities. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Improvement in spasticity
Interventions
- DRUG Baclofen bolus injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2016-04-22 |
| Est. Completion | 2019-02-01 |
| Phase | Phase 4 |
What the finished NCT02903823 record still lists
NCT02903823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Baclofen bolus injection is the first listed.
NCT02903823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02903823 about?
NCT02903823 is a clinical study titled "Intrathecal (IT) Baclofen Drug Distribution". The goal of this pilot study to determine whether there is a significant therapeutic advantage to place the ITB catheter within the cervical, thoracic or lumbar region of the spine. It is also a goal of this pilot study to determine whether the origin of spasticity influences the effect of Lioresal ...
What is the current status of trial NCT02903823?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2016-04-22. Estimated completion is 2019-02-01.
What interventions are being tested in trial NCT02903823?
The interventions under investigation include: Baclofen bolus injection (DRUG).
Who is sponsoring clinical trial NCT02903823?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02903823's enrollment target sits among peer trials
27 1651st of 2000 higher than 346 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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