New AAN/CNS Guideline on Treatment of Spasticity in Cerebral Palsy

Susan Jeffrey

January 29, 2010

January 29, 2010 — A new Practice Parameter from the American Academy of Neurology (AAN) and the Child Neurology Society provides new guidance on how to treat spasticity in children with cerebral palsy (CP).

For localized and segmental spasticity, the study authors concluded that botulinum toxin type A is generally safe and effective and gave it a Level A recommendation, although they acknowledge that the US Food and Drug Administration (FDA) is currently investigating cases of serious adverse events, including death, with use of this agent to treat spasticity in children.

"It puts us in a difficult situation, I guess, because here we have a medication that we know works, but it doesn't have FDA approval for that indication and now has a warning," lead author Mauricio R. Delgado, MD, from the University of Texas Southwestern Medical Center in Dallas, told Medscape Neurology.

This review, though, began about 4 years ago and was not prompted by the FDA actions, he noted. The new Practice Parameter is published in the January 26 issue of Neurology.

Spasticity in CP

CP affects more than 10,000 infants born each year in the United States. It is the most common cause of spasticity in children, and most children with CP have spasticity, the study authors note.

However, CP is a complex motor disorder, Dr. Delgado noted, and spasticity is only 1 feature of it. The decision to treat spasticity should be made by a multidisciplinary medical and surgical team, he said in a statement from AAN. "It is important that doctors, patients, and caregivers together set a goal for measuring the success of medication use or any other spasticity treatment."

In some cases, for example, spasticity can be used by the patient to their advantage, and treating it might actually reduce their function. In others, reducing spasticity can ease pain and muscle spasms, facilitate the use of a brace, improve posture, minimize contractures and deformity, facilitate mobility and dexterity, and improve a patient's ability for self-care.

For this review, they limited themselves to pharmacologic treatments. A panel of specialists, including a pediatric and an adult neurologist, developmental pediatricians, physiatrists, and an orthopedic surgeon, reviewed the literature from 1966 to 2008 and classified treatments according to the AAN classification system.

Their recommendations were as follows:

• For localized and segmental spasticity that warrants treatment, botulinum toxin type A should be offered as an effective and generally safe treatment, they write; "however, the Food and Drug Administration is presently investigating isolated cases of generalized weakness resulting in poor outcomes." (Level A);

• There were insufficient data, they note, to support or refute use of phenol, alcohol, or botulinum toxin type B as regional treatments (Level U);

• For generalized spasticity that warrants treatment, diazepam should be considered for short-term treatment (Level B) and tizanidine may be considered (Level C); and

• Again, there were insufficient data to draw conclusions about dantrolene, oral baclofen, or continuous intrathecal baclofen in generalized spasticity (Level U).

"That doesn't mean they don't work, I'm just saying there is no scientific evidence," Dr. Delgado noted of these Level U classifications in both regional and generalized spasticity. "I think it's important to understand that the lack of scientific evidence doesn't mean that we're against it."

More Research Critical

"I think the exercise of reviewing the literature is important because it allows us to review what we have and what we don't have, and I think the fact that we don't have scientific evidence for some of these medications that we use in clinic on a regular basis basically opens the door to do more research," Dr. Delgado said. "Many of the treatments that we use in pediatrics have been approved and tested in adults, and we translate that into children."

In addition, some of these older drugs, such as dantrolene and baclofen, were never formally tested in children. More research is needed to understand proper doses and ways to use these agents more safely, he added, as well as providing evidence that treating the spasticity will translate into improved function for these children.

"I think a lot of studies sometimes miss that point," he noted. "So here we are using over and over what we already have, but we're not satisfied. We need new treatments, we need to get more effective and safer treatments, and that's the bottom line."

Dr. Delgado serves on the editorial board of Developmental Medicine and Child Neurology; has received research support from Abbott, Sciele Pharma Inc, UCB, Allergan Inc, the Hurst Foundation, the United Cerebral Palsy Research & Educational Foundation, the Linda and Don Carter Foundation, and the Crowley Carter Foundation; and estimates that 50% of his clinical effort is spent on assessment of management of motor disorders of childhood, which includes treating children with CP with oral antispasticity medications, intrathecal baclofen, and botulinum toxin injections. Disclosures for the other authors appear in the paper.

Neurology. 2010;74:336-343.

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