Intrathecal (IT) Baclofen Drug Distribution

Muscle Spasticity Clinical Trial

— ITB  

Official title:

Intrathecal (IT) Baclofen Drug Distribution Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903823
• Other study ID #: 151399
• Status: Completed
• Phase: Phase 4
• Start date: April 22, 2016
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

While ITB therapy is commonly recommended for treatment of severe spasticity due to a variety of diseases, the location of optimal drug (baclofen) delivery has not been defined in a controlled study. Furthermore, the cost of pharmacological management in these patients is significant, and optimal location for drug delivery through an implantable drug pump may have significant impact on the cost burden of maintenance refills. It is 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. In studying the impact of catheter location among patients with spinal versus cerebral origin of spasticity, the disease origin may also have a significant impact on baclofen dosing relative to the placement of the catheter.

In addition, the pharmacokinetic half-life and the variability of intrathecal baclofen is poorly understood as data is limited. In order to provide initial data regarding CSF baclofen washout, samples of spinal fluid obtained just prior to- and following IT baclofen administration will be obtained for delayed analysis. The results of these pharmacological analysis may refine the understanding of how quickly baclofen is distributed from a given catheter location, and whether it is affected by catheter location or disease origin. Since multiple catheter locations will be studied within a given patient, it also affords the opportunity to sample small amounts of CSF at key anatomical sites along the spinal axis as a secondary objective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Adult patients with spasticity from spinal origin (spinal cord injury)

2. Adult patients with spasticity of cerebral origin (cerebral palsy and cerebrovascular accident)

3. Adult women of child bearing age with a negative pregnancy test

Exclusion Criteria:

1. Patients with spasticity from Multiple sclerosis

2. Pregnant women

3. Patients under the age of 18 years

4. Patients over the age of 50

5. Patients who are unable to have an MRI scan of the total spine

6. Patients with spinal deformity that would prevent easy access to the lumbar intrathecal space

7. Patients who have an allergic reaction to IT baclofen

8. Patients who have significant headache from CSF withdrawal

9. Patients who have intradural blockage that prevents advancing the IT catheter to the level of C4

Related Conditions & MeSH terms

• Muscle Spasticity

Intervention

Drug:
• Baclofen bolus injection
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.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (6)

Albright AL, Turner M, Pattisapu JV. Best-practice surgical techniques for intrathecal baclofen therapy. J Neurosurg. 2006 Apr;104(4 Suppl):233-9. — View Citation

Albright AL. Technique for insertion of intraventricular baclofen catheters. J Neurosurg Pediatr. 2011 Oct;8(4):394-5. doi: 10.3171/2011.7.PEDS11211. — View Citation

Coffey JR, Cahill D, Steers W, Park TS, Ordia J, Meythaler J, Herman R, Shetter AG, Levy R, Gill B, et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg. 1993 Feb;78(2):226-32. — View Citation

Grabb PA, Guin-Renfroe S, Meythaler JM. Midthoracic catheter tip placement for intrathecal baclofen administration in children with quadriparetic spasticity. Neurosurgery. 1999 Oct;45(4):833-6; discussion 836-7. — View Citation

Kroin JS, Ali A, York M, Penn RD. The distribution of medication along the spinal canal after chronic intrathecal administration. Neurosurgery. 1993 Aug;33(2):226-30; discussion 230. — View Citation

Penn RD. Catheter implant systems for intrathecal drug delivery. J Neurosurg. 1996 Apr;84(4):713. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin	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 was a reduction in MAS score by 1 point across a joint tested. Maximal MAS change is the sum of MAS score reduction in all four limbs tested.; This outcome looks at subjects with spasticity of cerebral origin.	Baseline to 6 hours post-injection
Primary	Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Spinal Origin	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 was a reduction in MAS score by 1 point across a joint tested. Maximal MAS change is the sum of MAS score reduction in all four limbs tested.; This outcome looks at subjects with spasticity of spinal origin.	Baseline to 6 hours post-injection

External Links

•   NANS 2018 ePoster