The study will involve an evaluation of the efficacy and safety of ramelteon (TAK-375) over a 6-month period in adults and elderly subjects with chronic insomnia. The test agent ramelteon will be used at 8 mg fixed dose and the study will be conducted in multiple sites.

Official Title

A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia

Conditions

Chronic Insomnia

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

  • Reduction in latency to persistent sleep.

Study Start

July 2005; Expected completion: November 2006

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • Subjects will be at least 18 years of age, male or female with a usual bedtime between 10 PM and 1 AM.
  • Subjects have had difficulty initiating or maintaining sleep, or of nonrestorative sleep, that lasts at least 3 months and that causes significant distress or difficulty in social, occupational, or other important areas of function.
  • The disturbance in sleep does not occur exclusively during the course of another sleep disorder or mental disorder and is not the direct physiological effect of a substance or a general medical condition.
  • Subjects generally report sleeping less than 6.5 hours per night, and it takes more than 45 minutes to get to sleep.

Exclusion Criteria:

  • Subjects who have known hypersensitivity to ramelteon or related compounds, including melatonin.
  • Use of melatonin, sedative-hypnotic, stimulants, or other drugs/supplements known to affect sleep/wake function, within 1 week (or 5 half lives of the drug, whichever is the longer) prior to the first day of single-blind study medication.
  • The subject has had sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of single-blind study medication. The subject has flown across greater than 3 time zones within 21 days prior to or during screening.
  • The subject has ever had a history of seizures, sleep apnea, RLS, PLMS, COPD, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder, or subjects with a history of alcohol/drug abuse within the past 12 months.

Total Enrolment

476

Contact Details

Locations:

  • Adelaide, Australia
  • Camperdown, Australia
  • Victoria, Australia
  • Melbourne, Australia

Shoona Vincent, PhD, DM: svincent@tgrd.comDavid JB Kim, B.S: dkim@tgrd.com

All content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.