Trial Name:

Insomnia Phase 3 Research Study

Description:

GenesisCare is seeking participants for an international clinical trial on a new study drug for the treatment of insomnia, not caused by any other diseases.

Eligibility Criteria:

  • age over 18 years old
  • willingness and capability to sign informed consent
  • capability to work independently with electronic diary (smart phone)
  • diagnosis of insomnia for at least 3 months
  • absence of other diseases or medications, that could cause insomnia
  • usual bedtime between 21:30 and 00:30 (you cannot participate in the study if you are a shiftworker)

Benefits to participate in the study:

  • treatment by specialists in Australia with the help of most up-to-date technology
  • reimbursement of travel and allowance expense
  • contribution and support to worldwide research for a new treatment of insomnia

Obligations connected with participation in the study:

  • need to come regularly to study site (in total 8 night stays during approximately 5 months)
  • to fill in personal diary independently, based on the instructions from study team members every day
  • duty to return unused study drugs and wallets from used study drugs

Study Details:

Clinical study participants will be divided into three different groups. Two groups will receive different doses of the new study drug and another group will receive placebo (non-active drug).
Enrolment into one of three different groups is random (decided by chance) and neither the investigator nor participants will know to which group they belong. During the course of study, participants will be medically monitored during regular visits to the study site by means of most up-to-date equipment and procedures. The Physician will provide you with more detailed information and an explanation of the whole study. They will answer any questions you may have and provide you with written information about the study.
This clinical study was approved by relevant Ethics committees.

Study Location:

RiverCity Private Hospital, Brisbane

Principal Investigator:

Dr Sophie Williams, Sleep & Respiratory Physician

For further information or with patient referrals, please contact:

Study Coordinators:
Judy Jeffrey
Email: judy.jeffrey@genesiscare.com
Phone: 38588919

Sonia Nelson
Email: Sonia.nelson@genesiscare.com
Phone: 38588918