A double-blind placebo controlled cross-over study to determine if 1.5 and 3mg of APL510 can normalise sleep patterns in elderly subjects with difficulty in maintenance of sleep and/or initiating sleep onset. - N/A
- Conditions
- Difficulty in maintenance of sleep and/or initiating sleep onset
- Registration Number
- EUCTR2004-003939-32-GB
- Lead Sponsor
- Alliance Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;<br> Secondary Objective: 1. To determine the term safety profile of APL510<br><br> 2. To determine the ease of withdrawal of APL510<br> ;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.
- Secondary Outcome Measures
Name Time Method