Fatigue in Sarcoidosis: Treatment with Methylphenidate

  • Research type

    Research Study

  • Full title

    Fatigue in Sarcoidosis - A feasibility study investigating the treatment of fatigue in stable sarcoidosis patients using methylphenidate

  • IRAS ID

    190280

  • Contact name

    Chris Atkins

  • Contact email

    c.atkins@uea.ac.uk

  • Sponsor organisation

    Norfolk and Norwich University Hospital

  • Eudract number

    2016-000342-60

  • Clinicaltrials.gov Identifier

    NCT02643732

  • Duration of Study in the UK

    1 years, 8 months, 7 days

  • Research summary

    Sarcoidosis is a disease caused by a build-up of nodules around the body made up of cells from the immune system. It can affect any organ in the body and causes a wide array of problems. It has been demonstrated previously that fatigue affects over half of sarcoidosis patients, significantly affecting quality of life. Even when the disease has been adequately treated patients are often left with chronic fatigue as a result of their disease.

    One proposed treatment of this debilitating fatigue is using neurostimulant drugs such as methylphenidate. These have been shown to be effective in other causes of fatigue (such as cancer sufferers), and in one very small study was shown to improve fatigue scores in sarcoidosis patients. We have also treated two patients in clinic with good effect. However, more evidence is needed to suggest that this treatment should be an option for wider use. Furthermore, there are questions which need to be answered to help design a suitable trial to provide this evidence.

    We propose a feasibility trial of 30 patients with stable sarcoidosis and fatigue. Patients will receive either methylphenidate (initially 10mg twice daily, increasing to 20mg twice daily) or an identical dummy pill (placebo) over six months. Patients will be allocated at random to one of the two groups; eighteen will receive methylphenidate, twelve will receive placebo. This will allow more data to be collected on tolerability of the study drug. Patients and the researchers will be unaware of which treatment they will receive. Patients will answer questionnaires, perform walking tests and breathing tests, and be monitored for side effects.

    We aim to determine: How quickly patients can be recruited into the study and how many of these patients will complete the study. We also want to know whether patients stop taking the medications, and for what reason; whether patients receiving the medication experience any side effects; and whether taking the drug makes people feel better about themselves (“quality of life”) and how tired/fatigued they are.

  • REC name

    East of England - Cambridge Central Research Ethics Committee

  • REC reference

    16/EE/0087

  • Date of REC Opinion

    21 Jun 2016

  • REC opinion

    Further Information Favourable Opinion