E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053851 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable for this study is the mean latency to persistent sleep (LPS) of 2-night PSG.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last patient
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |