Chronic insomnia MedDRA version: 8 Level: LLT Classification code 10053851
Conditions
Interventions
Product Name: ramelteon
Product Code: TAK-375
Pharmaceutical Form: Tablet
Current Sponsor code: TAK-375
Concentration unit: % percent
Concentration type: range
Concentration number: 90--110
Pharmaceut
Sponsors
Takeda Global R&D Centre (Europe)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General • Subjects will be =18 years of age • Subjects must also be in good health, capable of understanding and willing to provide signed informed consent, and who meet other inclusion criteria specified in the protocol Study-specific • Habitual bedtime for each subject must be between 10 pm to 1 am. • Difficulty initiating or maintaining sleep or of nonrestorative sleep that lasts at least 3 months. • Insomnia causes clinically significant distress or impairment 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. • Difficulty sleeping is not due to the direct physiological effects of a substance or a general medical condition. • sTST less than 6.5 hours per night, and sSL greater than or equal to 45 minutes. • Mean latency of >20 minutes on two consecutive screening nights - with neither night less than 15 minutes. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General • Subjects with a history of alcohol / drug abuse within the last 12 months • Subjects must not be taking any protocol specified exclusionary medications or supplements, and must not meet any other exclusion criteria outlined in the protocol • Subjects may be excluded by an Investigator if he/she feels that participation is not in the subject(s) best interest Study-specific • 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 singleblind study medication. • Apnoea hypnoea index and periodic leg movement (per hour of sleep) >10 respectively, as seen on PSG during the first night of PSG screening. • The subject has sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication. • The subject has flown across greater than three 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the long-term efficacy of ramelteon once daily in reduction of latency to persistent sleep (LPS) compared to placebo in subjects with chronic insomnia.;Secondary Objective: To evaluate long term treatment effects of ramelteon in improvement of sleep latency and duration objectively and subjectively. To evaluate the long term safety of ramelteon in the insomniac population.;Primary end point(s): The primary efficacy variable for this study is the mean latency to persistent sleep (LPS) of 2-night PSG. | — |
Countries
Czech Republic, Finland, Germany, Italy
Outcome results
None listed