A study of MK4305 in the treatment of insomnia

• Research type

  Research Study

• Full title

  A Phase IIb, Multicenter, Randomised, Double-Blind Placebo-Controlled, 2-period Adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK4305 in Patients with Primary Insomnia

• IRAS ID

  8796

• Sponsor organisation

  Merck & Co., Inc.

• Eudract number

  2008-006018-97

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study will assess the efficacy and safety of a new medication for the treatment of insomnia (inadequate or poor quality sleep).Chronic (long term) insomnia affects up to one-third of the adult population, with more than 50% of affected people experiencing significant daytime consequences such as reduced energy, memory problems, and difficulty concentrating.Insomnia may also be associated with negative effects on physical and mental wellbeing, reflected in higher levels of depression, anxiety, and diminished quality of life.There is a need for new treatments for insomnia as traditional treatments such as benzodiazepines (e.g. valium) can be addictive, cause drowsiness the following day and memory disturbance. The drug being tested in this study works in a different way to currently available insomnia drugs and it is hoped that it will promote restful sleep without the side-effects associated with current treatments.This will be the first study to evaluate the effectiveness of this new drug in improving sleep in patients with insomnia.Patients will be in the study for about 3 months and will attend the clinic on about 9 occasions. In one part of the study they will take the study drug and for another part they will take an inactive look-alike tablet called placebo so that we can see if the study drug improves their sleep compared to the placebo. Patients will have to stay in the sleep centre overnight on 6 occasions so that their brainwaves and other measurements of sleep can be assessed.The study is being conducted at specialist sleep research units at LCG-Bourn in Cambridge and the Edinburgh Sleep Centre.The research is being funded by the pharmaceutical company that's developing the study drug.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  08/H0406/225

• Date of REC Opinion

  28 Jan 2009

• REC opinion

  Further Information Favourable Opinion