Trial Outcomes & Findings for Intrathecal (IT) Baclofen Drug Distribution (NCT NCT02903823)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

27 participants

Primary outcome timeframe

Baseline to 6 hours post-injection

Results posted on

2022-02-22

Participant Flow

All subjects recruited through Vanderbilt University Adult Neurosurgery group in Nashville, TN. Intent was to enroll subjects until 20 completed the study. Hence 7 more subjects were enrolled than completed. That makes 27 that started the study and 20 completed it. .

Participant milestones

Participant milestones
Measure	Baclofen Injection at Designated Spinal Level 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. 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.
Overall Study STARTED	27
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Baclofen Injection at Designated Spinal Level 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. 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.
Overall Study Physician Decision	5
Overall Study Could not advance catheter	1
Overall Study Catheter dislodgement	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baclofen Injection at Designated Spinal Level n=21 Participants 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. 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.
Age, Categorical <=18 years	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=21 Participants
Age, Continuous	43 years n=21 Participants
Sex: Female, Male Female	8 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=21 Participants
Region of Enrollment United States	21 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to 6 hours post-injection

Population: Subjects with pre-surgical diagnosis of 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.

Outcome measures

Outcome measures
Measure	Subjects With Max MAS Change n=20 Participants Days 2,3,4,5 a baclofen injection bolus will be given in the catheter, located at C4, T3, 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. 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.
Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin Cervical level 4 injection site	8 Participants
Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin Thoracic level 3 injection site	7 Participants
Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin Thoracic level 10 injection site	3 Participants
Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin Lumbar lever 2 injection site	3 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subjects With Max MAS Change n=20 Participants Days 2,3,4,5 a baclofen injection bolus will be given in the catheter, located at C4, T3, 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. 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.
Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Spinal Origin Cervical spine level 4 injection site	4 Participants
Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Spinal Origin Thoracic level 3 injection site	2 Participants
Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Spinal Origin Thoracic level 10 injection site	5 Participants
Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Spinal Origin Lumbar level 2 injection site	3 Participants

Adverse Events

Baclofen Injection at Designated Spinal Level

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Baclofen Injection at Designated Spinal Level n=27 participants at risk Days 2,3,4,5 a baclofen injection bolus will be given in the catheter, located at C4, T3, 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. 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.
Nervous system disorders Catheter dislodgement	3.7% 1/27 • Number of events 1 • 5 days

Additional Information

Peter Konrad, MD PhD - PI

Vanderbilt University Medical Center

Phone: 6153439822

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place