Melatonin for Nocturia in MS

• Research type

  Research Study

• Full title

  A randomized, double blind, placebo controlled, cross over trial of Melatonin for the treatment of nocturia in adults with progressive multiple sclerosis, with an open label, single-arm extension study

• IRAS ID

  112976

• Contact name

  Marcus Drake

• Sponsor organisation

  North Bristol NHS Foundation Trust

• Eudract number

  2012-004183-21

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is to assess the effect of melatonin in patients with Multiple Sclerosis (MS). Melatonin is a natural hormone regulating circadian cycles; it is released by the brain's pineal gland at night-time, and varying with sleep state. It also reduces smooth muscle activity in the bladder. MS is a neurological disease affecting the myelin coat on nerve fibres. In primary and secondary progressive MS urinary symptoms are common, including Nocturia, along with sleep disturbance from other causes (e.g. restless legs syndrome, anxiety, etc.). Quality of life impact is substantial; fatigue leads to reduced capacity to carry out daily activities, which is a particular problem in a disabled patient group. Melatonin has been used for Nocturia in two small studies, in men with benign prostate enlargements, and also in a group of elderly patients; both groups showed a beneficial symptom response in addition to improving their quality of life. This trial is a double-blind randomised placebo controlled crossover clinical trial to compare sustained-release melatonin against placebo in patients with Multiple Sclerosis. A run-in phase will be followed by two treatment phases (active drug or placebo) of 6 weeks each separated by a wash-out interval of 1 month. After the second treatment phase, patients will be entitled to participate in an open label, single-arm extension study of duration one year. Qualitative interviews will be undertaken with participants to assess the impact of Nocturia on their quality of life.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  12/SW/0322

• Date of REC Opinion

  25 Jan 2013

• REC opinion

  Further Information Favourable Opinion