Using modafinil as a treatment for severe fatigue in Inflammatory Bowel Disease

What the researchers will look at?

Fatigue is a common symptom of Crohn’s and Colitis. It affects half the people living with these conditions. Although fatigue is common, there are not many medicines that can treat it. Researchers think that a medicine called modafinil could help treat fatigue.

Modafinil is currently used to treat narcolepsy. This is a condition that affects a person's ability to stay awake. Modafinil works by increasing the amount of dopamine in the brain. Dopamine is a chemical that is naturally found in the body and helps control energy levels. 

This research is a “feasibility study”. This means it will test whether it is possible or worth doing a larger version of the study. This type of study is needed because there have been no previous studies of modafinil in people living with Crohn’s or Colitis.

Researchers will recruit adults who experience fatigue as part of Crohn’s or Colitis. These adults will be asked to take one tablet twice a day for 12 weeks. This tablet will either be modafinil or a placebo. A placebo is a substance that looks the same as the treatment but does not have any medicine in it. The patients will not know which tablet they have been given and nor will the researchers. This is called a randomised controlled trial.

Researchers will measure:

• How many people join the study
• How many complete the treatment
• How many of the prescribed tablets people take
• How acceptable people felt the trial was
• They will ask people about their fatigue, mental health, and symptoms at 6 and 12 weeks during the trial.

The researchers will use the results of these measures to work out if it is possible to do a larger scale study.

What the researchers think this could this mean for people with Inflammatory Bowel Disease?

The researchers hope this study will lead to larger clinical trials of using modafinil to treat fatigue. If successful, they hope this will lead to modafinil being widely used as an effective treatment for people living with fatigue and Crohns or Colitis. They also think it will lead to more research into new treatments for fatigue.

Who is leading this research: Dr Calum Moulton, King's College London
Our funding: £149,679.42
Duration: 24 months 
Official title of application: Modafinil for severe fatigue in Inflammatory Bowel Disease: A placebo-controlled, feasibility randomised controlled trial.