An anti-fatigue therapy has yielded a significant reduction in chronic tiredness for stroke survivors involved in a 15-month clinical trial at the Hunter Medical Research Institute, with transformative quality-of-life benefits for many of the participants.
Lead researcher Dr Andrew Bivard, from the University of Newcastle, says the benefits of the drug Modafinil were universally borne out in study results just published in the international journal Stroke, with zero placebo impact and no adverse effects reported.
One patient reduced his daily sleep times from up to 28 hours a week to just 45 minutes, while almost tripling his walking distance.
“Fatigue is the most common post-stroke problem that people face, more so than a physical disability. It affects concentration to the point where they can’t do everyday tasks, so fatigue has a huge impact on the quality of life of stroke survivors ” Dr Bivard said.
“We saw more than a 10 per cent improvement in self-reported fatigue, which also resulted in an quality-of-life increase that, to our knowledge, hasn’t previously been achieved in a stroke survivor population.”
The Phase 2 ‘MIDAS’ trial enrolled 36 recruits from the John Hunter Hospital stroke clinic, all of whom were experiencing severe, debilitating fatigue while living at home. They ranged from a minimum of three months post-stroke to two years.
The trial was a crossover design where all participants received both the placebo and drug – they were then measured for factors such as fatigue, quality of life, cognition and mood, Dr Bivard said. “Surprisingly we saw no change in mood but we did see an improvement in cognition, with people able to think more clearly,” he added.
Modafinil was developed in the 1980s as a safe and affordable agent for treating a range of sleep disorders. According to Dr Bivard, it stimulates the release of histamine, serotonin, dopamine and orexin but clears the body within 72 hours of cessation.
A daily dosage of 200 milligrams was specified during MIDAS, half that of the normal minimum prescribed dose, and a majority of participants have since opted to continue taking the drug.
From the trial, the investigators have also collected MRI scans and will continue their study to identify the effects on the brain and to search for a fatigue biomarker.
“We’re now planning a Phase 3 international trial that will aim to recruit 400 patients. If successful, we believe this will make a big difference for thousands of stroke survivors,” Dr Bivard said.
* Dr Andrew Bivard, the current HMRI Early Career Researcher of the Year, is from the University of Newcastle, researching in conjunction with HMRI’s Brain and Mental Health Program.
The University of Newcastle, Australia