Narcolepsy drug moves to Phase III trial for post-stroke fatigue


13 Sep 2018

Australian researchers are hoping to build on promising results for modafinil in debilitating fatigue after stroke with a larger phase III trial.

The MIDAS trial, published last year in Stroke, found that modafinil effectively alleviated fatigue and improve quality of life in patients who had experienced a stroke.

And according to study author Dr Tom Lillicrap of the NHMRC Centre of Research Excellence (CRE) in Stroke Rehabilitation and Brain Recovery at the University of Newcastle, NSW, a larger trial, MIDAS 2, is now recruiting patients.

In the initial MIDAS study the “wakefulness-promoting agent” modafinil, which is primarily used to treat the sleeping disorder narcolepsy, was assessed in a six-week randomised controlled trial in 36 stroke survivors.

It found that participants receiving modafinil reported a significant decrease in fatigue (multidimensional fatigue inventory, −7.38) and improved quality of life (SSQoL, 11.81) compared with placebo.

“Even more gratifying than the statistical results were the individual stories from patients who took part in the trial,” says Dr Lillicrap.

“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 at the Royal Adelaide Hospital, the Royal Melbourne Hospital and John Hunter Hospital, Newcastle, NSW.

“This trial may provide the evidence needed to have modafinil listed on the PBS for post-stroke fatigue,” says Dr Lillicrap.

“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.”

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