E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Difficulty in maintenance of sleep and/or initiating sleep onset |
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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 determine the efficacy of 1.5 and 3.0mg of APL510 in the management of insomnia defined as self-reported poor sleep quality, in the elderly. |
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E.2.2 | Secondary objectives of the trial |
1. To determine the term safety profile of APL510
2. To determine the ease of withdrawal of APL510
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male or female subjects aged 65 years or more presenting with self-reported poor sleep quality defined as at least two of the following: a) Regularly takes more than 45 minutes to fall asleep. b) Overall night time sleep less than 5 hours on at least 3 nights per week. c) Regular night time awakenings defined as at least twice per night on at least 3 nights per week.
2. Subjects with a poor sleep quality for at least 8 weeks.
3. Written informed consent. |
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E.4 | Principal exclusion criteria |
1. Have a clinically significant unstable medical abnormality, chronic disease or history or presence of significant neurological, hepatic, renal, endocrine, cardiovascular, GI, pulmonary, psychiatric, metabolic disease or malignancy which in the opinion of the investigator would preclude successful participation in the study.
2. Have a recent history of (< 2 years) alcohol or drug abuse or current evidence of substance dependence or abuse as defined by DSM-IV criteria.
3. Have major depression or anxiety causing sleep disturbance as defined by DSM-IV criteria.
4. Had a clinically significant illness within the last 30 days.
5. Routine biochemistry parameters (e.g creatinine or LFTs) not greater than 2 x the ULN for this age of population. Haemoglobin less than 10
6. Subjects receiving B6 or B12 supplements (multivitamin supplements are allowable provided intake does not exceed the recommended daily dose).
7. Subjects planning to travel through more than 2 time zones whilst entered into the study.
8. Subjects with a known hypersensitivity to melatonin or any of the excipients in the formulation.
9. Subjects who, by virtue of the need to care for a close family member, are subjected to intermittent night-time disturbance.
10. Subjects who have experienced the bereavement of a close family member within the last 3 months.
11. Subjects who have used any other investigational drug within the last 30 days.
12. Subjects planning to work night shifts.
13. Subjects on treatment with anxiolytics, antidepressants, anticonvulsants, hypnotics or strong narcotic analgesics within the last 30 days. Other narcotic analgesics are allowed if they have ben used at a constant dose for at least the last 30 days, the dose is unlikely to change during the duration of the study and in the opinion of the investigator, not likely to interfere with the subject’s sleep quality. Subjects receiving hypnotics are eligible for the study if they consent to withdraw from treatment for 30 days prior to screening
14. Subjects with a known severe allergic or auto-immune disease.
15. Subjects with other conditions that may cause night time awakenings (e.g. nocturia or pain) that in the investigator’s opinion would interfere with the assessment of the subject’s sleep disturbance.
16. Subjects who, in the opinion of the investigator, are unlikely to complete the study satisfactorily.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary measure of efficacy will be the increase in the subjects’ total sleep time as recorded by sleep diaries and wrist actigraphy. |
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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 | 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 | Yes |
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 | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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Once 53 (up to 80) subjects have been recruited. |
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |