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 | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022437 |
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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 |
To investigate the efficacy of treatment with Org 50081 compared to placebo in elderly subjects with chronic primary insomnia. Primary efficacy variable is Wake time After Sleep Onset (WASO), averaged over all in-treatment time points and measured by polysomnography (PSG). |
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E.2.2 | Secondary objectives of the trial |
To investigate PSG defined latency to persistent sleep (LPS); To investigate subjective reports of efficacy, using electronic diaries; To investigate the safety and tolerability of Org 50081 in elderly subjects; To investigate rebound and discontinuation effects in elderly subjects. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subjects are eligible to participate in the trial, if they: 1. are at least 65 years of age at screening; 2. sign written informed consent after the scope and nature of the investigation have been explained to them, before screening evaluations; 3. are able to speak, read and understand the language of the investigator, study staff (including raters) and the informed consent form, and possess the ability to respond to questions, follow instructions and complete questionnaires; 4. have demonstrated capability to independently complete the Logpad questionnaires and have completed the questionnaires at least 6 out of 7 days of the week preceding randomization; 5. have a regular sleep pattern, meaning bedtime regularly occurs between 2100 and 2400, with no more variation from these boundaries than 2 times/ week, with 5-8.5 hours in bed; 6. have a documented diagnosis of chronic primary insomnia, defined as fulfillment of the DSM-IV criteria for primary insomnia (DSM-IV 307.42) with a duration of ≥ 1 month; fulfill the following PSG criteria on the two screening/baseline PSG nights: 7. average TST < 6.5 h (and each night ≥ 3 h and < 7 h), 8. average WASO ≥ 45 minutes (and each night ≥ 30 min), 9. average LPS ≥ 15 min (and each night ≥ 10 min). |
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E.4 | Principal exclusion criteria |
Exclusion criteria Potential participants will be excluded if they: 10. have other sleep disorders (DSM-IV-TR), such as sleep related breathing disorders (AHI ≥ 15), periodic leg movements with arousals (PLMAI ≥10), restless leg syndrome, narcolepsy, circadian sleep wake rhythm disorders, REM behavioral disorder or any parasomnia; 11. have any significant medical or DSM-IV-TR psychiatric illness causing the sleep disturbances; 12. currently meet diagnostic criteria for DSM-IV-TR depression (MDD) or have been diagnosed and treated for MDD within the last 2 years; 13. have a history of bipolar disorder or family history of suicide; 14. have a history or signs of dementia or other serious cognitive impairment, as defined by a score of less than 26 on the Mini-Mental State Examination; 15. have a significant, unstable medical illness e.g. acute or chronic pain, hepatic, renal, metabolic or cardiac disease ; 16. had serious head injury or stroke within the past year, or a history of (non-febrile) seizures; 17. have clinically relevant ECG abnormalities at screening, as judged by the investigator; 18. have clinically relevant abnormal hematology or biochemistry values at screening, as judged by the investigator; 19. have DSM-IV-TR substance abuse or DSM-IV-TR addiction within the last year; 20. drink more than 2 alcoholic drinks in a day; One drink is approximately equal to: 12 oz or 360 ml of beer (regular or light), or 4 oz or 120 of red or white wine (e.g. port or sherry), or 12 oz or 360 ml of wine cooler (regular or light) or 1 oz or spirits(80 to 100 proof, e.g. whiskey, vodka); 21. are routinely sleeping during daytime (napping) for more than 20 minutes per day, 3 days or more per week; 22. are night workers or rotating shift workers currently, or in the past 6 months; 23. are traveling, or have plans to travel, through more than three time zones during the trial, from the screening visit onwards; |
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E.5 End points |
E.5.1 | Primary end point(s) |
The Wake time after Sleep Onset (WASO), average over all double -blind treatment time points and measured by polisomnography (i.e.m mean of Nights 1,2, 15 and 16 for PSG data). |
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
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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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 | 2 |