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Lioresal Intrathecal (Baclofen Injection) - Summary

 
 



Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.  
Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms.  Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal.  Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

 

SUMMARY

LIORESAL INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic.

LIORESAL INTRATHECAL is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of LIORESAL INTRATHECAL via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. LIORESAL INTRATHECAL (baclofen injection) is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of LIORESAL INTRATHECAL into the intrathecal space.

Spasticity of Spinal Cord Origin: Evidence supporting the efficacy of LIORESAL INTRATHECAL was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of LIORESAL INTRATHECAL to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. LIORESAL INTRATHECAL was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms.

Spasticity of Cerebral Origin: The efficacy of LIORESAL INTRATHECAL was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury. The first study, a randomized controlled cross- over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; LIORESAL INTRATHECAL was superior to placebo in reducing spasticity as measured by the Ashworth Scale. A second cross- over study was conducted in 11 patients with spasticity arising from brain injury. Despite the small sample size, the study yielded a nearly significant test statistic (p= 0.066) and provided directionally favorable results. The last study, however, did not provide data that could be reliably analyzed.

LIORESAL INTRATHECAL therapy may be considered an alternative to destructive neurosurgical procedures. Prior to implantation of a device for chronic intrathecal infusion of LIORESAL INTRATHECAL, patients must show a response to LIORESAL INTRATHECAL in a screening trial (see Dosage and Administration).


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NEWS HIGHLIGHTS

Media Articles Related to Lioresal Intrathecal (Baclofen Injection)

Muscle Spasms
Source: MedicineNet Amyotrophic Lateral Sclerosis Specialty [2014.07.14]
Title: Muscle Spasms
Category: Diseases and Conditions
Created: 6/16/2009 12:00:00 AM
Last Editorial Review: 7/14/2014 12:00:00 AM

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Published Studies Related to Lioresal Intrathecal (Baclofen Injection)

The lack of efficacy of different infusion rates of intrathecal baclofen in complex regional pain syndrome: a randomized, double-blind, crossover study. [2011.03]
OBJECTIVE: Intrathecal baclofen (ITB) is effective in the treatment of dystonia related to complex regional pain syndrome (CRPS). In a previous study, we noted that the responsiveness to ITB declined in 30% of patients once drug delivery was switched from an external to an implanted device associated with a reduction of the infusion rate (IR)... CONCLUSIONS: Increasing the IR at a fixed daily dose is not associated with improvement of dystonia or pain but warrants further investigation in patients in whom side effects prevent further dose escalation. Wiley Periodicals, Inc.

Intrathecal clonidine and baclofen enhance the pain-relieving effect of spinal cord stimulation: a comparative placebo-controlled, randomized trial. [2010.07]
OBJECTIVE: Spinal cord stimulation (SCS) is a well-established treatment for neuropathic pain; nevertheless, 40% of patients fail to obtain satisfactory pain relief and in many patients, the effect tends to diminish with time. Based on animal experiments, intrathecal baclofen was previously introduced clinically to enhance suboptimal SCS effects. Later animal experiments demonstrated similar data for clonidine. The aim of this study was to elucidate whether intrathecal clonidine or baclofen enhances the effect of SCS in neuropathic pain patients in whom the pain relieving-effect of SCS is inadequate... CONCLUSION: A trial with clonidine and baclofen combined with SCS may be warranted in patients who do not obtain satisfactory pain relief with SCS alone or experienced a decreasing therapeutic effect.

Intrathecal clonidine and baclofen enhance the pain-relieving effect of spinal cord stimulation: a comparative placebo-controlled, randomized trial. [2010]
whom the pain relieving-effect of SCS is inadequate... CONCLUSION: A trial with clonidine and baclofen combined with SCS may be

Intrathecal baclofen for postoperative analgesia after total knee arthroplasty. [2009.11]
STUDY OBJECTIVE: To determine whether intrathecal baclofen is an effective adjunctive agent to decrease acute and chronic postoperative pain after total knee arthroplasty... CONCLUSIONS: IT baclofen used as an adjuvant to spinal anesthesia for total knee arthroplasty allows for less postoperative opioid usage and less chronic pain at three months.

Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial. [2009.05]
BACKGROUND: Intractable spasticity can be treated effectively with continuous infusion of intrathecal baclofen. Because evidence for its use in the treatment of children with spastic cerebral palsy is lacking, we conducted a randomised controlled trial. AIMS: To test whether continuous infusion of intrathecal baclofen is effective in comparison with standard treatment only... CONCLUSION: The results of this randomised controlled trial establish continuous infusion of intrathecal baclofen to be effective in carefully selected children with problems caused by intractable spastic cerebral palsy.

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Clinical Trials Related to Lioresal Intrathecal (Baclofen Injection)

Baclofen for Smoking Cessation in a Non-Psychiatric Population [Recruiting]
The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures.

The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i. e. take the medication as directed for the trial period) than those in the placebo group.

The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco withdrawal and craving ratings as compared to placebo.

Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity [Recruiting]
Oral baclofen is used commonly to treat spasticity in children with cerebral palsy. Although for adults there is dosing,safety and efficacy information in the package insert, this is not the case for children. The purpose of this study is to determine how fast the drug is cleared from the body, the correct dose, and long-term safety and efficacy for children with spasticity.

Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump [Not yet recruiting]

Oral and IV Baclofen in Adult Volunteers [Not yet recruiting]
The primary objective of this study is to characterize baclofen pharmacokinetics following oral and intravenous administration in patients who are on chronic oral baclofen therapy. The secondary objective is to determine the safety profile of an IV baclofen formulation.

This study is a randomized crossover study with two treatment arms. All subjects will receive a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or intravenous form is given on the first study day will be randomized in a 1: 1 manner.

The pharmacokinetic and tolerability information gained from this study will support the development of further studies to assess the use of IV baclofen to prevent or treat baclofen withdrawal syndrome.

Transcranial Magnetic Stimulation (TMS) Measures of Plasticity and Excitatory/Inhibitory Ratio as Biomarkers: R-baclofen Effects in Normal Volunteers [Recruiting]
Our overall objective is to apply Transcranial Magnetic Stimulation (TMS) to develop measures of human synaptic plasticity and of brain excitatory: inhibitory ratio (E: I ratio), which we propose as novel biomarkers and outcome measures that will expedite clinical trials of treatments for Autism Spectrum Disorder (ASD). One potential therapeutic agent, R-baclofen will be investigated under this protocol.

TMS is a safe, inexpensive and noninvasive means to focally stimulate the human brain. Presently, TMS is in extensive use as a means to measure regional brain excitability, which is dependent on local synaptic strength. TMS can be used to temporarily alter synaptic strength as well as to acutely measure levels of cortical excitability and short and long interval inhibition. Since altered synaptic plasticity and an imbalanced inhibitory: excitatory ratio are cited as fundamental abnormalities in ASD, we hypothesize that both severity of ASD-related learning deficits and their improvement after therapy will correlate with TMS measures of synaptic plasticity and E: I ratio. We propose to embed TMS measures of synaptic plasticity and E: I ratio in a 'Proof of Principal' trial of R-baclofen and to examine:

Aim 1: Whether R-baclofen (a potential therapeutic agent for ASD) predictably alters TMS measures of synaptic plasticity and E: I ratio as a function of plasma concentration in adult volunteers. We will test the following hypotheses:

1. R-baclofen produces a significant change in TMS measures of LTD and E: I ratio; and

2. R-baclofen plasma levels and TMS measures of LTD and E: I ratio show a predictable exposure-response relationship.

Exploratory Aim 1: Whether the presence of genetic polymorphisms of the BDNF and GABA-B receptor genes has a moderating effect on TMS measures and on R-baclofen effects. We will test the following hypotheses:

1. Presence of the BDNF val66met allele will be associated with decreased long-term depression (LTD) of cortical excitability

2. Polymorphisms of GABA-B receptor genes will be associated with altered magnitude of response to R-baclofen as measured by TMS

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Page last updated: 2014-07-14

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