Protocol for a randomized, placebo-controlled, double-blind phase IIa study of the safety, tolerability, and symptomatic efficacy of the ROCK-inhibitor Fasudil in patients with Parkinson's disease (ROCK-PD).

Background: The Rho-kinase (ROCK) inhibitor Fasudil has shown symptomatic and disease-modifying effects in Parkinson's disease (PD) models in vitro and in vivo. In Japan, Fasudil has been approved for the treatment of subarachnoid haemorrhage since 1995 and shows a favourable safety profile. Objectives/design: To investigate the safety, tolerability, and symptomatic efficacy of ROCK-inhibitor Fasudil in comparison to placebo in a randomized, national, multicenter, double-blind phase IIa study in patients with PD. Methods/analysis: We plan to include 75 patients with at least 'probable' PD (MDS criteria), Hoehn and Yahr stages 1-3, and age 30-80 years in 13 German study sites. Patients must be non-fluctuating and their response to PD medication must have been stable for 6 weeks. Patients will be randomly allocated to treatment with the oral investigational medicinal product (IMP) containing either Fasudil in two dosages, or placebo, for a total of 22 days. As primary analysis, non-inferiority of low/high dose of Fasudil on the combined endpoint consisting of occurrence of intolerance and/or treatment-related serious adverse events (SAEs) over 22 days will be assessed in a sequential order, starting with the lower dose. Secondary endpoints will include tolerability alone over 22 days and occurrence of treatment-related SAEs (SARs) over 22 and 50 days and will be compared on group level. Additional secondary endpoints include efficacy on motor and non-motor symptoms, measured on established scales, and will be assessed at several timepoints. Biomaterial will be collected to determine pharmacokinetics of Fasudil and its active metabolite, and to evaluate biomarkers of neurodegeneration. Ethics/registration/discussion: After positive evaluation by the competent authority and the ethics committee, patient recruitment started in the 3rd quarter of 2023. ROCK-PD is registered with Eudra-CT (2021-003879-34) and clinicaltrials.gov (NCT05931575). Results of this trial can pave way for conducting extended-duration studies assessing both symptomatic efficacy and disease-modifying properties of Fasudil.

Handling of hazardous drugs - Effect of an innovative teaching session for nursing students.

BACKGROUND: Imparting knowledge and practical skills in hazardous drug handling in nursing students' education is essential to prevent hazardous exposure and to preserve nurses' health. OBJECTIVES: This study aimed at comparing routine nursing education with an additional innovative teaching session. DESIGN: A prospective controlled study in nursing students was conducted in two study periods: (i) a status-quo period (routine education on handling hazardous drugs) followed by (ii) an intervention period (additional innovative teaching session on handling hazardous drugs). SETTINGS/PARTICIPANTS: Nursing students at a vocational school were invited to participate voluntarily. METHODS: In both study periods (i) and (ii), the following factors were analysed: (a) knowledge of hazardous drug handling by questionnaire, (b) practical skills in hazardous drug handling (e.g. cleaning) by a simulated handling scenario, (c) contamination with drug residuals on the work surface by fluorescent imaging. RESULTS: Fifty-three nursing students were enrolled. (a) Median knowledge improved from status-quo (39% right answers) to intervention (65%, p<0.001), (b) practical skills improved from status-quo (53% of all participants cleaned the work surface) to intervention (92%, p<0.001). (c) Median number of particles/m2 decreased from status-quo to intervention (932/97, p<0.001). CONCLUSIONS: Compared with routine education, knowledge and practical skills in hazardous drug handling were significantly improved after an innovative teaching session. Additionally, the amount of residuals on the work surface decreased. This indicates a lower risk for hazardous drug exposure.

Managing of oral medicines in paediatric oncology: can a handbook and a pharmaceutical counselling intervention for patients and their parents prevent knowledge deficits? A pilot study.

OBJECTIVES: To assess knowledge deficits of patients/parents and prevention strategies. METHODS: After receiving ethics approval, we performed a controlled, quasi-randomised, prospective intervention study. We enrolled patients/parents involved in managing oral medicines in three groups: control (routine care only), handbook intervention and pharmaceutical counselling intervention group. At baseline and after the interventions, we assessed patients'/parents' knowledge deficits (incorrect or missing answers) by questionnaire. RESULTS: We enrolled 64 patients/parents. At baseline, knowledge deficits among the groups were similar: 17% in controls, 22% in the handbook group and 24% in the pharmaceutical counselling group. After the intervention, knowledge deficits decreased to 13% in the handbook group and to 8% in the pharmaceutical counselling group (NS; p=0.003 compared with controls, respectively). For controls, knowledge deficits remained almost unchanged (19%). Results for the pharmaceutical counselling group showed a strong correlation between baseline knowledge deficits and the extent of the deficit decrease after the intervention (τ=-0.74; p<0.001), whereas no significant correlation was found in the control or handbook group. CONCLUSIONS: In paediatric oncology, patients'/parents' knowledge of managing oral medicines was improved. Pharmaceutical counselling substantially reduced high knowledge deficits but no significant improvement was seen with the handbook approach. Pharmaceutical counselling should be offered to patients/parents with high knowledge deficits to reduce errors in managing medicines and increase safety.