CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 27 enrolled
Drug / intervention
Baclofen bolus injectiondrug
Likely dose
Baclofen bolus injection 50 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02903823
NCT02903823Phase 4Completed
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Intrathecal (IT) Baclofen Drug Distribution Pilot Study

Vanderbilt University·interventional·Posted Sep 16, 2016·Updated Feb 22, 2022

In Brief

A Phase 4 clinical trial evaluating Baclofen bolus injection for Muscle Spasticity. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMuscle Spasticity
CountriesUnited States
CollaboratorsMedtronic

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 16, 2016
Enrollment StartApr 22, 2016
Primary CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.8 years ago

Interventions

Baclofen bolus injectiondrug

A baclofen bolus injection (50 micrograms) will be administered daily after the patient returns from radiology to position catheter injection location. The injection may be given at C4, T4, T10 or L2 spinal locations depending on the catheter tip location.