News Briefs From the 65th Annual Meeting of the American Academy of Neurology

In the second study, Dr. Hauser and colleagues tested whether a new drug could aid patients who have taken levodopa for years and are experiencing longer periods of off time. The researchers assigned 420 participants who had an average of six hours of off time per day to treatment with placebo or to one of four dosages of tozadenant, in addition to their usual dose of levodopa, for 12 weeks. Off time decreased by slightly more than an hour from baseline for patients who received two of the dosages of tozadenant. Subjects who received tozadenant did not have dyskinesia during their on time.

The third study focused on 321 patients with early Parkinson's disease whose symptoms were not well controlled by a dopamine agonist. Dr. Hauser and his colleagues assigned the patients to either rasagiline or placebo, in addition to their dopamine agonist, for 18 weeks. At the end of the study, scores on a Parkinson's disease rating scale improved by 2.4 points for subjects who had received rasagiline. The drug was well tolerated and had adverse events similar to those of the placebo.

Can Hormone Therapy Help Treat MS Long-Term?
Treatment with adrenocorticotropic hormone (ACTH) may be helpful for patients whose multiple sclerosis (MS) is not well controlled through their regular treatment, according to the results of a pilot study.

Regina Berkovich, MD, PhD, from the Keck Medical Center of the University of Southern California in Los Angeles, presented her findings during the Emerging Science session at the 65th Annual Meeting of the American Academy of Neurology.

The study involved 23 patients with MS who were taking interferon beta and who had Expanded Disability Status Scale (EDSS) scores of 3.0 to 6.5 and at least one relapse or new T2 or gadolinium-enhanced lesion within the previous year. Study participants were given either ACTH (80 units IM once/day on three consecutive days) or methylprednisolone (1 gram IV as one dose) as pulse therapy monthly in addition to their regular treatment for one year. The patients with MS knew which treatment they were receiving, but the researchers examining them were blinded to the treatment regimen.

The participants were tested every three months for 15 months. During that time, those receiving ACTH had fewer relapses, or 0.08 cumulative relapses per patient, compared with 0.8 relapses per patient for those receiving methylprednisolone. Those taking ACTH also had no cases of psychiatric side effects, while those taking methylprednisolone had a cumulative number of 0.55 psychiatric episodes per patient.

"These results are of interest, because few treatments are available for people with breakthrough MS," said Dr. Berkovich. "Further studies, including randomized controlled trials, are needed to validate these preliminary findings, but the results suggest a potential benefit of ACTH pulse therapy in breakthrough MS."

Although ACTH gel has been approved for use in MS relapses for many years, its cost has limited its use to only those patients who are in need of a relapse treatment alternative to corticosteroids. This is believed to be the first study to have been conducted regarding its use as a chronic treatment for MS. ACTH is not FDA-approved for use as a chronic treatment for MS.

Early Detection of PML May Improve Survival and Reduce Disability
Early detection of progressive multifocal leukoencephalopathy (PML) may reduce mortality and disability levels in patients with multiple sclerosis (MS), according to a study presented at the 65th Annual Meeting of the American Academy of Neurology. The research could have implications for patients with MS who receive natalizumab, which increases the risk of PML.

Tuan Dong-Si, MD, Medical Director at Biogen Idec in Weston, Massachusetts, and colleagues examined 319 individuals with MS who were treated with natalizumab and diagnosed with PML. The investigators compared patients who had symptoms of PML at the time of diagnosis with patients who had no symptoms of PML but were diagnosed with the disease by brain scans and spinal fluid tests for John Cunningham virus. Patients' level of disability was assessed before the PML diagnosis, at the time of the diagnosis, six months after the diagnosis, and one year after the diagnosis.

Twenty-one participants had no PML symptoms at the time of their diagnosis, and 298 individuals had symptoms. The study's preliminary data suggest that patients who have no symptoms at diagnosis may have improved survival and less disability than those who had developed symptoms before their diagnosis, according to Dr. Dong-Si.

At the time of PML diagnosis, individuals without symptoms had an average score of 67 on the Karnofsky Performance Scale. In contrast, participants with symptoms had an average score of 54. One year after PML diagnosis, the average Karnofsky score of patients with no symptoms at diagnosis was 70, compared with 47 for patients with symptoms at diagnosis.