Muscle SpasticityPhase 4ITBNCT02903823

Intrathecal (IT) Baclofen Drug Distribution

A Phase 4 study testing Baclofen bolus injection in people with Muscle Spasticity, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Muscle Spasticity
What is being tested?: Baclofen bolus injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 22 Apr 2016to 1 Feb 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Intrathecal (IT) Baclofen Drug Distribution Pilot Study

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.

Read the detailed 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.

Conditions: Muscle Spasticity
Being tested: Baclofen bolus injection
Keywords: spinal cord injury, cerebral palsy, stroke
Medical subject headings: Muscle Spasticity, Spinal Cord Injuries, Cerebral Palsy, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Baclofen bolus injectionDrug
Also called Injection of baclofen bolus
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.

Study groups in NCT02903823
Study group	Role	What they receive
Baclofen injection at designated spinal level	Experimental	Days 2,3,4,5 a baclofen injection bolus will be given in the catheter, located at C4, T4, T10 and L2 respectively. Effect of baclofen injection (50 microgram bolus) upon rigidity will be assessed manually using the Modified Ashworth rating score for selected upper and lower extremities. Receives: Drug: Baclofen bolus injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 6 hours post-injection
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.
Measured: Baseline to 6 hours post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 20161 Feb 2019

First posted16 Sep 2016 (estimated)
Study start22 Apr 2016
Primary completion1 Feb 2019
Study completion1 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Muscle SpasticityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02903823
Sponsor's protocol ID: 151399
Acronym: ITB
Status last verified: Feb 2022
First submitted: 26 Aug 2016
Last updated: 22 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Penn RD. Catheter implant systems for intrathecal drug delivery. J Neurosurg. 1996 Apr;84(4):713. doi: 10.3171/jns.1996.84.4.0713a. No abstract available.
PubMed 8613874
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.
PubMed 7690122
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. doi: 10.1097/00006123-199910000-00020.
PubMed 10515478
Albright AL. Technique for insertion of intraventricular baclofen catheters. J Neurosurg Pediatr. 2011 Oct;8(4):394-5. doi: 10.3171/2011.7.PEDS11211.
PubMed 21961547
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. doi: 10.3171/jns.1993.78.2.0226.
PubMed 8421205
Albright AL, Turner M, Pattisapu JV. Best-practice surgical techniques for intrathecal baclofen therapy. J Neurosurg. 2006 Apr;104(4 Suppl):233-9. doi: 10.3171/ped.2006.104.4.233.
PubMed 16619633

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
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All Muscle Spasticity trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intrathecal (IT) Baclofen Drug Distribution Pilot Study
ClinicalTrials.gov ID: NCT02903823
Acronym / sponsor ID: ITB / 151399
Conditions: Muscle Spasticity
Keywords: spinal cord injury, cerebral palsy, stroke
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Collaborators: Medtronic
Study start: 22 Apr 2016 (actual)
Primary completion: 1 Feb 2019 (actual)
Study completion: 1 Feb 2019 (actual)
First posted: 16 Sep 2016 (estimated)
Results: Posted 27 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Baclofen injection at designated spinal level	Experimental	Drug: Baclofen bolus injectionDays 2,3,4,5 a baclofen injection bolus will be given in the catheter, located at C4, T4, T10 and L2 respectively. Effect of baclofen injection (50 microgram bolus) upon rigidity will be assessed manually using the Modified Ashworth rating score for selected upper and lower extremities.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Baclofen bolus injectionAlso: Injection of baclofen bolusA 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.	Drug	Baclofen injection at designated spinal level

Primary outcome

Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin
Time frame: Baseline to 6 hours post-injection
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.
Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Spinal Origin
Time frame: Baseline to 6 hours post-injection
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.

Results and safety

Results posted to the registry on 27 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Baclofen Injection at Designated Spinal Level	27	20

Primary outcome: Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin

Time frame: Baseline to 6 hours post-injection. Count of participants. Unit: Participants

Measure	Subjects With Max MAS Change n = 20
Cervical level 4 injection site	8
Thoracic level 3 injection site	7
Thoracic level 10 injection site	3
Lumbar lever 2 injection site	3

Population analysed: Subjects with pre-surgical diagnosis of spasticity of cerebral origin.

Primary outcome: Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Spinal Origin

Time frame: Baseline to 6 hours post-injection. Count of participants. Unit: Participants

Measure	Subjects With MAS Change - Based on Site of Injection n = 20
Cervical spine level 4 injection site	4
Thoracic level 3 injection site	2
Thoracic level 10 injection site	5
Lumbar level 2 injection site	3

Adverse events

Time frame: 5 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Baclofen Injection at Designated Spinal Level	0 of 27 (0%)	1 of 27 (3.7%)	0 of 27

Limitations and caveats (from the sponsor): Small number of subjects. Non-randomized trial. Inter-rater variability of assessments.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8613874Penn RD. Catheter implant systems for intrathecal drug delivery. J Neurosurg. 1996 Apr;84(4):713. doi: 10.3171/jns.1996.84.4.0713a. No abstract available.
Background: PubMed 7690122Kroin 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.
Background: PubMed 10515478Grabb 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. doi: 10.1097/00006123-199910000-00020.
Background: PubMed 21961547Albright AL. Technique for insertion of intraventricular baclofen catheters. J Neurosurg Pediatr. 2011 Oct;8(4):394-5. doi: 10.3171/2011.7.PEDS11211.
Background: PubMed 8421205Coffey 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. doi: 10.3171/jns.1993.78.2.0226.
Background: PubMed 16619633Albright AL, Turner M, Pattisapu JV. Best-practice surgical techniques for intrathecal baclofen therapy. J Neurosurg. 2006 Apr;104(4 Suppl):233-9. doi: 10.3171/ped.2006.104.4.233.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Baclofen bolus injection in people with Muscle Spasticity, run by Vanderbilt University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin (time frame: Baseline to 6 hours post-injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02903823, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.