Phase 4 Completed N=27 Basic Science

Intrathecal (IT) Baclofen Drug Distribution

Muscle Spasticity

Source: ClinicalTrials.gov NCT02903823 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcomePrimary: Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin — 8; 7; 3; 3 Participants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin	8; 7; 3; 3	—
PRIMARY Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Spinal Origin	4; 2; 5; 3	—

Eligibility Criteria

Inclusion Criteria

Adult patients with spasticity from spinal origin (spinal cord injury)
Adult patients with spasticity of cerebral origin (cerebral palsy and cerebrovascular accident)
Adult women of child bearing age with a negative pregnancy test

Exclusion Criteria

Patients with spasticity from Multiple sclerosis
Pregnant women
Patients under the age of 18 years
Patients over the age of 50
Patients who are unable to have an MRI scan of the total spine
Patients with spinal deformity that would prevent easy access to the lumbar intrathecal space
Patients who have an allergic reaction to IT baclofen
Patients who have significant headache from CSF withdrawal
Patients who have intradural blockage that prevents advancing the IT catheter to the level of C4

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02903823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.