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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022437 |
E.1.2 | Term | Insomnia |
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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 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 functioning using the Functional Outcomes of 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 (after each night of treatment). -To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo after 6 and 12 weeks of treatment.
Open treatment phase extension: 40 weeks duration: - To evaluate patient’s daytime functioning using the Functional Outcomes Sleep Questionnaire with eplivanserin 5mg/day during 52 weeks of treatment. - To evaluate the clinical safety of eplivanserin 5mg/day during the 52 weeks with eplivanserin treatment. - To assess the effect on sleep following abrupt discontinuation (after 52 weeks) of study treatment with eplivanserin 5mg/day (during run-out period). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Out- patients,
2) Age ≥18 years old,
3) Each patient must have primary insomnia based on criteria (DSM-IV-TR- Axis I) with predominant complaints of difficulty in initiating or maintaining sleep (nocturnal awakenings), or nonrestorative sleep for at least one month preceding the study visit,and having clinically significant distress or impairment in social occupational or other important areas of functioning,
4) Based on patient’s information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks,
5) Based on patient’s information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month,
6) Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit. To be included patient’s answer should be either: 2 (=Somewhat interfering), or 3 (=Much), or 4 (=Very Much Interfering),
7) Based on the information recorded in the patient’s diary during the screening week preceding the randomization the following criteria must be present: a) Mean WASO per night ≥ 60mn during screening period (7 days) and no period of WASO < 45mn on each screening night. However, one night with WASO < 45min during screening period is acceptable. In addition, one lowest WASO value will be excluded from the calculation of the mean WASO. b) TST ≤ 7 hours and ≥ 3 hours on 3-worst screening nights. c) Mean SOL per night have to be ≤ 30mn during the screening period. One highest SOL value will be excluded from the calculation of mean SOL. |
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E.4 | Principal exclusion criteria |
- Females who are lactating or who are pregnant, - Woman of childbearing potential with a positive serum beta-human chorionic gonadotropin (bHCG) pregnancy test at screening and not using an acceptable form of contraception, - Patients presenting with acute or chronic pain resulting in insomnia, - Patients with current psychiatric disturbances - Patients with a history of epilepsy or seizures, with clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, with history of serious head injury or stroke - Patients with clinically significant and abnormal ECG (including QTc≥ 500ms), - Use of any prescription or OTC sleep medication - Use of substances with psychotropic effects or porperties 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. - Lifetime history of diverticulitis or sigmoiditis
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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 | Yes |
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 | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |