E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sleep maintenance insomnia |
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MedDRA Classification |
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 assess efficacy of eplivanserin 5mg/day in comparison to placebo after 6 and 12 weeks of treatment on sleep maintenance insomnia using patient sleep questionnaires (pr-WASO) |
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E.2.2 | Secondary objectives of the trial |
- To evaluate patient's daytime functionning using the Funtional Outcomes Sleep Questionnaire (FOSQ) with eplivanserin 5mg/day as compared to placebo after 6 and 12 weeks of treatment. - To evaluate residual effects (using patient's morning questionnaire) that may be associated with eplivanserin 5mg/day as compared to placebo during double-blind treatment period. - To compare the effect on sleep following abrupt discontinuation (after 12 weeks) between eplivanserin 5mg/day and placebo. - To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo - To document eplivanserin and the main metabolite SR141342 plasma concentrations. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male and female out-patients ≥ 18 years old. - Diagnosis of primary insomnia based on criteria (DSM-TR-IV) with predominant complaints of difficulty in initiating or maintaining sleep (nocturnal awakenings), or nonrestorative sleep for at least one month preceding the study visit.
(1) Based on patient’ s information: Patient has spent at least 6.5 hours and no more than 9.0 hours, in bed, each night, over the preceding two weeks. Patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month. - Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening and randomization visits.
(2) Based on the information recorded in the patient’s diary during the screening week a) WASO ≥ 60mn per night during screening period (7 days) and no WASO < 45mn on each screening night b) TST < 7 hours and > 3 hours on 3-worst screening nights c) mean SOL have to be ≤ 30mn during the screening period |
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E.4 | Principal exclusion criteria |
- Lactating or pregnant women - Women of child bearing potential with a positive serum BHCG pregnacy test at screening visit, and not using an acceptable form of contraception - Patients presenting with acute or chronic pain resulting in insomnia - Patients with current psychiatric disorders - Patients with history of epilepsy or seizures, with any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, with history of serious head injury or stroke - Clinically significant and abnormal ECG - Use of any prescription or OTC sleep medication - Use of substance with psychotropic effects or properties known to affect sleep/awake
- Night shift workers, and individuals who nap 3 or more times per week over the preceding month, - History of (i) primary hypersomnia, (ii) narcolepsy, (iii) breathing-related sleep disorder, (iv) circadian rhythm sleep disorder, (v) parasomnia (e.g. somnambulism), (vi) dyssomnia not otherwise specified, i.e. periodic leg movement syndrome.
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E.5 End points |
E.5.1 | Primary end point(s) |
Wake time after sleep onset using patient's sleep questionnaire (pr-WASO) |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | 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 | 11 |
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 | 11 |