The use of APL510 to improve the length of day time sleep in subjects working permanent night-shifts

Phase 2

Completed

• Conditions: Insomnia; Mental and Behavioural Disorders; Nonorganic sleep disorders

• Registration Number: ISRCTN15733268
• Lead Sponsor: Alliance Pharmaceuticals Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-15
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Male or female subjects aged 18 to 65 years working permanent night-shifts with at least three consecutive night-shifts in their shift pattern
2. A female subject could be included if:
2.1. She was of non-child-bearing potential (e.g., post-menopausal for 1 year, had undergone bilateral tubal ligation, had undergone a hysterectomy or was physiologically incapable of becoming pregnant), or
2.2. She was of childbearing potential practising 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 was not an acceptable reason for inclusion), or
2.3. Total abstinence from sexual intercourse was maintained
3. Provided written informed consent
4. No planned absences from work, other than rest days, for the duration the subject was in the study. Subjects could work additional night-shifts as overtime

Exclusion Criteria

1. Clinically significant unstable medical abnormality, chronic disease or history or presence of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, 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. A recent history (less than 2 years) of alcohol or drug abuse or current evidence of substance dependence or abuse as defined by Diagnostic and Statistical Manual of Mental Disorders-IV criteria, with the exception of nicotine dependence
3. Female subjects who were pregnant, not using an adequate form of contraception or 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
6. Subjects receiving hypnotics, tricyclic antidepressants, monoamine oxidase inhibitors, serotonin reuptake inhibitors, lithium, beta-blockers, calcium channel blockers, central alpha-blockers, non-steroidal anti-inflammatory drugs (excluding occasional over-the-counter use), alprazolam, triazolam, neuroleptics, or barbiturates. Subjects receiving any of these compounds were eligible for entry provided the medication was stopped 2 weeks prior to study entry.
7. Subjects with a known history of impaired hepatic or renal function defined as transaminases greater than 2 x the upper limit of normal or creatinine clearance of less than 35 mL/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 had received an experimental drug within the previous 3 months
10. Subjects using melatonin
11. Subjects, who, by virtue of the need to care for close family members, might have been subjected to intermittent disturbance during their daytime rest periods
12. Subjects who, in the opinion of the Investigator, were not capable of completing the study
13. Subjects who did not consent to their General Practitioner being informed of their participation in the study

Pregnant or breast feeding women were excluded as the preclinical data on melatonin in this group were not available at the start of the study. Subjects were advised that caution should be exercised when driving or operating any heavy or dangerous machinery within 6 hours of taking a dose of study medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean total sleep time over the days on which diary entries were recorded.<br><br>Measured throughout the study and the data was averaged or tabulated after completion of the study.

Secondary Outcome Measures

Name	Time	Method
1. Mean number of daytime awakenings<br>2. Potential hangover effects<br><br>Measured throughout the study and the data was averaged or tabulated after completion of the study.