by Dr Tom Lillicrap
Fatigue is a common, and often debilitating symptom in stroke survivors. For many patients, fatigue improves on its own over the first 2-3 months after their stroke. However, fatigue that persists beyond 3 months will often continue for many months or years afterwards. Severe fatigue interferes with a person’s ability to participate in rehabilitation activities, return to work or even just socialise with their friends and family. There are currently no proven therapies for post-stroke fatigue, but the Modafinil in Debilitating Fatigue After Stroke (MIDAS) trial aimed to remedy this by testing the drug Modafinil. Modafinil is a “wakefulness-promoting agent” which is primarily used to treat the sleeping disorder narcolepsy.
The MIDAS trial assigned patients to receive either Modafinil or placebo every day for 6 weeks, followed by a washout period to allow all the drug to leave their system, after which patients swapped treatments. This means that those who had been taking Modafinil began taking placebo, and those who had been taking placebo began taking Modafinil. Neither the patient nor the researchers knew which tablets were Modafinil and which were placebo. We performed a number of tests on patients before they started each course of tablets, and at the end of each course. These tests measured fatigue levels, quality of life and cognition.
In the results of the trial, published last year in Stroke, we found that Modafinil did effectively alleviate fatigue and improve quality of life. Even more gratifying than the statistical results (which allowed us to set up a larger phase III clinical trial) were the individual stories from patients who took part in the trial. Three patients managed to return to work which had been impossible due their level of fatigue. One of these patients had suffered his stroke after his wedding. With returning to work and having more energy, he and his wife were able to plan the honeymoon they never got to take. Another patient finally had enough energy to stay awake and leave the house in afternoon. He appreciated most being able to take his teenage daughter to lunch and to the beach, an experience she had not had with her dad for as long as she could remember.
The larger trial, MIDAS 2, is being run across multiple hospitals: The Royal Adelaide Hospital (SA), Royal Melbourne Hospital – City campus (Parkville, Victoria) and John Hunter Hospital – New Lambton (NSW). This trial may provide the evidence needed to have Modafinil listed on the PBS for post-stroke fatigue. This is an important step as the drug is quite expensive (costing around $160 per month) and for many stroke survivors, this cost is beyond their means.
The trial is registered on the Australian NewZealand Clinical Trials Registry (ACTRN12618000602224).
If you wish to participate in this trial: