Rotigotine effects on early morning motor function and sleep in Parkinson's disease: a double-blind, randomized, placebo-controlled study (RECOVER).

In a multinational, double-blind, placebo-controlled trial (NCT00474058), 287 subjects with Parkinson's disease (PD) and unsatisfactory early-morning motor symptom control were randomized 2:1 to receive rotigotine (2-16 mg/24 hr [n = 190]) or placebo (n = 97). Treatment was titrated to optimal dose over 1-8 weeks with subsequent dose maintenance for 4 weeks. Early-morning motor function and nocturnal sleep disturbance were assessed as coprimary efficacy endpoints using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Examination) measured in the early morning prior to any medication intake and the modified Parkinson's Disease Sleep Scale (PDSS-2) (mean change from baseline to end of maintenance [EOM], last observation carried forward). At EOM, mean UPDRS Part III score had decreased by -7.0 points with rotigotine (from a baseline of 29.6 [standard deviation (SD) 12.3] and by -3.9 points with placebo (baseline 32.0 [13.3]). Mean PDSS-2 total score had decreased by -5.9 points with rotigotine (from a baseline of 19.3 [SD 9.3]) and by -1.9 points with placebo (baseline 20.5 [10.4]). This represented a significantly greater improvement with rotigotine compared with placebo on both the UPDRS Part III (treatment difference: -3.55 [95% confidence interval (CI) -5.37, -1.73]; P = 0.0002) and PDSS-2 (treatment difference: -4.26 [95% CI -6.08, -2.45]; P < 0.0001). The most frequently reported adverse events were nausea (placebo, 9%; rotigotine, 21%), application site reactions (placebo, 4%; rotigotine, 15%), and dizziness (placebo, 6%; rotigotine 10%). Twenty-four-hour transdermal delivery of rotigotine to PD patients with early-morning motor dysfunction resulted in significant benefits in control of both motor function and nocturnal sleep disturbances.

Cavernous sinus syndrome, an atypical presentation of tertiary syphilis: case report and review of the literature.

Cavernous sinus syndrome is rarely caused by tertiary syphilitic infection. To our knowledge only two other cases of cavernous sinus syndrome caused by syphilis have been reported in the literature. We report a case of a 62-year-old female who presented with a mass in the cavernous sinus, which was initially diagnosed as a meningioma radiologically, necessitating a biopsy for diagnostic confirmation. Clinical features of syphilitic aortitis and subsequent positive neurosyphilis laboratory results lead to the suspicion of a gumma infiltrating the cavernous sinus. Empirical treatment with penicillin in an attempt to defer the need for biopsy led to both significant clinical improvement and radiological resolution. This confirmed the diagnosis of a syphilitic gumma in the cavernous sinus. In this paper we emphasize the rarity of cavernous sinus syndrome as a result of syphilitic infection, highlight the diagnostic difficulties using current serological and radiological measures, and propose treating intracerebral mass lesions in serum positive cases empirically prior to more invasive measures.

Evaluation of acceptance and commitment therapy for drug refractory epilepsy: a randomized controlled trial in South Africa--a pilot study.

PURPOSE: Psychological interventions in the treatment of epilepsy have been developed and evaluated for many years but the amount of research has hardly made an impact on how epilepsy is treated. The purpose of this study was to develop and evaluate a psychological treatment program consisting of acceptance and commitment therapy (ACT) together with some behavioral seizure control technology shown to be successful in earlier research. METHODS: The method consisted of a randomized controlled trial group design with repeated measures (n=27). All participants had an EEG verified epilepsy diagnosis with drug refractory seizures. Participants were randomized into one of two conditions, ACT or supportive therapy (ST). Therapeutic effects were measured by examining changes in quality of life (SWLS and WHOQOL) and seizure index (frequency x duration). Both treatment conditions consisted of only nine hours of professional therapy distributed in two individual and two group sessions during a four-week period. RESULTS: The results showed significant effects over all of the dependent variables for the ACT group as compared to the ST group at six- and twelve-month follow-ups. CONCLUSIONS: The results from this study suggest that a short-term psychotherapy program combined with anticonvulsant drugs may help to prevent the long-term disability that occurs from drug refractory seizures.