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1. Please use the following case to answer questions 1 through 3:
AW is a 52-year-old male diagnosed with amyotrophic lateral sclerosis (ALS) after developing right-hand weakness, which significantly affected his ability to use a computer at work and play golf with his friends, followed by dysarthric speech. He is interested in completing paperwork to start edaravone since he has been reading about it on ALS patient forums.

His laboratory findings and medical history are as follows:
• Complete metabolic panel: normal
• Current medications: duloxetine 30 mg by mouth daily and fish oil 1 gram by mouth daily
• ALSFRS-R score: 36 with deductions taken for speech, cutting food, and handwriting; each section has a score of 3 or more
• Time since symptom onset: 12 months
• Forced vital capacity (FVC): 82% of predicted

What is the best evidence-based answer regarding whether edaravone is expected to show benefit for patients like AW?

A. More information is needed to determine if his diagnosis is familial or sporadic ALS B. AW does not meet criteria for edaravone because his ALS symptom onset was more than 6 months ago C. More information is needed to determine his ALFRS-R score decline in the preceding 3 months D. AW meets criteria for the patient population expected to benefit from edaravone (i.e., to slow loss of function) E. Unsure

2. AW has been approved for edaravone and will start his first infusion next week. He calls you concerned because he forgot to ask about whether he should be taking riluzole. What is the most accurate answer based on available trial data?

A. Patients in the edaravone trial were not allowed to take concomitant riluzole B. Patients in the edaravone trial were allowed to continue riluzole if started prior to the trial C. Patients were required to take concomitant riluzole to participate in the edaravone trial D. Patients taking (or not taking) concomitant riluzole was not addressed by edaravone study investigators E. Unsure

3. You answer AW's question regarding taking riluzole with edaravone. He would like to know what to expect for side effects with riluzole and edaravone. What is the most appropriate answer?

A. Riluzole was frequently discontinued by patients in the clinical trials due to elevated liver function tests (e.g., greater than 3 times the upper limit of normal [ULN]) or neutropenia B. Edaravone was frequently discontinued by patients in the clinical trial due to nausea C. Riluzole can worsen tests of liver function, so monitoring is recommended during the first few months and periodically thereafter D. Edaravone requires monthly monitoring of coagulation parameters due to incidence of bleeding E. Unsure

4. KP is a 72-year-old female with bulbar-onset ALS. She no longer has intelligible speech but uses a whiteboard and marker quite effectively to communicate. She is increasingly distressed by outbursts of laughter and guttural sounds she cannot control. These episodes occur at least 4 times daily. She believes this is pseudobulbar affect and her neurologist has confirmed this diagnosis. What initial treatment and monitoring plan is most appropriate for KP?

A. Baseline CNS-LS score and trial dextromethorphan/quinidine 20 mg/10 mg for 12 weeks B. Baseline CNS-LS score and trial amitriptyline 100 mg by mouth at bedtime for 12 weeks C. Trial sertraline 50 mg by mouth daily for 1 week and ask patient to call clinic for update D. Baseline CNS-LS score and tell patient to try dextromethorphan 20 mg by mouth twice daily for 4 weeks E. Unsure

5. Edaravone is dosed by 4-week cycles. A patient would like to travel for 10 days to see family across the country. Their insurance has restricted the patient to infusion center administration only. Which of the following describes an appropriate consideration for this patient to continue edaravone?

A. Edaravone is dosed daily for 4 weeks so it must be held during vacation B. The patient could schedule their vacation during the “off” period of the cycle C. Edaravone should be administered via central intravenous access, so home administration is not appropriate D. Missed doses of edaravone should be handled using manufacturer's instructions E. Unsure

Evaluation Questions

6. How confident are in your treatment choices for the AW in the above questions?

A. Not at all confident B. Somewhat confident C. Confident D. Highly confident

7. How confident are in your treatment choices for the KP in the above questions?

A. Not at all confident B. Somewhat confident C. Confident D. Highly confident

Maintenance is scheduled for 8/7/2023 7:00 AM EST - 8:00 AM EST.

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2. AW has been approved for edaravone and will start his first infusion next week. He calls you concerned because he forgot to ask about whether he should be taking riluzole. What is the most accurate answer based on available trial data?

3. You answer AW's question regarding taking riluzole with edaravone. He would like to know what to expect for side effects with riluzole and edaravone. What is the most appropriate answer?

Evaluation Questions

6. How confident are in your treatment choices for the AW in the above questions?

7. How confident are in your treatment choices for the KP in the above questions?

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Maintenance is scheduled for 8/7/2023 7:00 AM EST - 8:00 AM EST.

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2. AW has been approved for edaravone and will start his first infusion next week. He calls you concerned because he forgot to ask about whether he should be taking riluzole. What is the most accurate answer based on available trial data?

3. You answer AW's question regarding taking riluzole with edaravone. He would like to know what to expect for side effects with riluzole and edaravone. What is the most appropriate answer?

Evaluation Questions

6. How confident are in your treatment choices for the AW in the above questions?

7. How confident are in your treatment choices for the KP in the above questions?

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