The effectiveness of intrathecal baclofen has been under study for over two decades now, in both North America and Europe. All studies have demonstrated it to be of use in the treatment of muscle spasticity and muscle spasms in the legs. Some centers are now starting to report its utility in treating other forms of hypertonia as well as its beneficial effects in hypertonia in the arms.
With regards to adults with spasticity due to injury of the spinal cord or multiple sclerosis, intrathecal baclofen has been shown to effectively relieve individuals of their debilitating spasticity over extended periods of time. A small group will require increasingly high doses of the drug, surpassing the pump’s ability to deliver or for the rest of the nervous system to tolerate. In this setting, a drug holiday is useful in decreasing the amount of drug required to deal with the spasticity. The intrathecal baclofen is then restarted at a lower dose after the holiday.
Studies are starting to emerge about using the drug intrathecally to treat children with spasticity due to cerebral palsy. In 1993, Albright reported on the beneficial effects of intrathecal baclofen given chronically to children with spasticity of the legs and arms. A multicenter study authored by Gilmartin et al. has been completed and was published in February 2000. The results of this study were used to support the application to the FDA for use of the drug in children with spasticity due to cerebral palsy. The FDA subsequently approved its use in children who have spasticity.