A study to evaluate safety and efficacy of MK4305 in insomnia (StudyA)

• Research type

  Research Study

• Full title

  A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients with Primary Insomnia – Study A

• IRAS ID

  48806

• Contact name

  Paul Robinson

• Sponsor organisation

  Merck Sharp & Dohme Corp.

• Eudract number

  2010-018413-30

• 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 difficultyconcentrating. 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 medicine being tested in this study works in a different way to currently available insomnia medicines and it is hoped that it will promote restful sleep without many of the side-effects associated with current treatments. Results from previous studies have indicated that the study medication may be effective in the treatment of insomnia, but we need to perform more studies to be sure of this. Patients will initially be in the study for about 4 months and will attend the clinic on about 8-10 occasions. Patients then have the option of continuing in the study for a further 3 months if they want to, and will attend the clinic a further 4 times. Patients will receive either the study medicine or an inactive look-alike tablet called placebo so that we can see how the study medicine improves sleep compared to the placebo. Most patients will have to stay in the sleep centre overnight on 6 occasions so that measurements of sleep such as brainwave activity can be assessed using monitoring equipment. The study is being conducted at The London Sleep Centre in Harley Street. The research is being funded by the pharmaceutical company that's developing the study medicine.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  10/H1208/28

• Date of REC Opinion

  9 Jun 2010

• REC opinion

  Further Information Favourable Opinion