E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Transient misalignment of the sleep-wake cycle as a result of working night shifts (insomnia in night shift workers)
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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 if the administration of 1.5mg APL510 can increase the length of daytime sleep following a night shift.
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E.2.2 | Secondary objectives of the trial |
1. To determine if the administration of 1.5mg APL510 can increase the maintenance of daytime sleep and reduce sleep latency and the number of episodes of disturbed sleep following a night shift.
2. To determine if the use of 1.5mg APL510 has any ‘hang-over’ effect during the night shift work period.
3. To compare the adverse event profiles of APL510 and placebo. |
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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 18-65 working permanent night shifts with at least 3 consecutive night shifts in their shift pattern.
A female subject may be included if:
She is of non-child-bearing potential (e.g. post-menopausal for one year, had bilateral tubal ligation, had a hysterectomy or is physiologically incapable of becoming pregnant), or
She is of childbearing potential practicing an acceptable method of birth control defined as the use of oral or depot hormonal contraception, an intrauterine contraceptive device or a combination of both spermicidal and barrier methods of contraception. A partner having had a vasectomy is not an acceptable reason for inclusion, or
Total abstinence from sexual intercourse is maintained.
2. Written informed consent. 3. No planned absences from work, other than rest days, for the duration the subject will be in the study.
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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 or other clinically relevant abnormality 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 (see Appendix VII). 3. Female subjects who are pregnant or not using an adequate form of contraception or who are breast-feeding. 4. Subjects receiving vitamins B6 and B12 supplements (excluding multivitamin supplements at recommended dose). 5. Subjects with a known hypersensitivity to melatonin or any of the excipients in the formulation. Excipients include: lactose, Methocel (methylcellulose), Aerosil (colloidal silicon dioxide), magnesium stearate, Opadry II (colourant). 6. Subjects receiving tricyclic antidepressants, monoamine oxidase inhibitors, serotonin re-uptake inhibitors, lithium, beta-blockers, calcium channel blockers, central alpha-blockers, non-steroidal anti-inflammatory agents (excluding occasional use of OTC NSAIDs), alprazolam, triazolam, neuroleptics, and barbiturates. Subjects currently receiving any of these compounds are eligible for entry provided the medication is stopped 2 weeks prior to study entry. 7. Subjects with a known history of impaired hepatic or renal function defined as transaminases > 2X the upper limit of normal or creatinine clearance of <35ml/min. 8. Subjects with a known severe allergic or auto-immune disease (e.g. multiple sclerosis, rheumatoid arthritis, severe asthma and systemic lupus erythematosus). 9. Subjects who have received an experimental drug within the previous 3 months. 10. Subjects who use melatonin. 11. Subjects, who, by virtue of the need to care for close family members, may be subjected to intermittent disturbance during their daytime rest periods. 12. Subjects who, in the opinion of the investigator, are not capable of completing the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary measure of efficacy will be a change in the subjects’ total sleep time. |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 44 (up to 60) evaluable 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 | 2 |
E.8.9.1 | In the Member State concerned days | |