A Single-Center, Randomized, Double-Blind, Double-Dummy Placebo Controlled, Cross-Over Study to Investigate the Next Morning Effects of Ramelteon (8mg), Zopiclone (7.5mg) and Placebo on Actual Driving Performance, Memory Functioning, Psychomotor Performance in Adults with Chronic Insomnia
- Conditions
- insomnia characterised by difficulty with sleep onsetMedDRA version: 10.0Level: PTClassification code 10040984Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2007-002875-15-NL
- Lead Sponsor
- Takeda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
1.The subject is male or female and aged 21 to 64 years, inclusive.
2.A female subject of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study. Women NOT of child bearing potential are defined as those who have been surgically sterilized (hysterectomy, oophorectomy, tubal ligation) or who are post-menopausal (defined as at least 2 years since last regular menses). Acceptable methods of contraception are defined in Section 9.1.9 Contraception and Pregnancy Avoidance Procedure.
3.The subject is capable of understanding and complying with protocol requirements.
4.The subject signs a written, informed consent form prior to the initiation of any study procedures.
5.The subject has a body mass index (BMI) between 18 and 34, inclusive.
6.Based on sleep history, the subject has had chronic insomnia for at least 3 months, as defined by the following:
a)The predominant complaint is difficulty initiating or maintaining sleep or non-restorative sleep for at least 3 months.
b)The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
c)The sleep disturbance does not occur exclusively during the course of Narcolepsy, Breathing-Related Sleep Disorder, Circadian Rhythm Sleep Disorder, or a Parasomnia.
d)The disturbance does not occur exclusively during the course of another mental disorder (eg, Major Depressive Disorder, Generalized Anxiety Disorder).
e)The disturbance is not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication) or a general medical condition.
7.Based on sleep history, the subject reports a history of sSL =60 min.
8.The subject must complete the PSQ-IVRS questionnaire on at least 5 of the 7 mornings during the single-blind placebo run-in, which will be scheduled between Days -14 and -3.
9.On at least 3 of the minimum 5 mornings for which PSQ-IVRS has been completed during the single-blind run-in period, the subject must have an sSL of =45 minutes as assessed via the PSQ-IVRS.
10.Based on sleep history, the subject’s habitual bedtime is between 23:00 and 01:00.
11.The subject is willing to have a fixed bedtime and agrees to go to bed within ?30 minutes of the habitual bedtime during the entire study.
12.Subjects have consistent access to a touch-tone phone and are willing to complete the PSQ-IVRS within 60 minutes of awakening each morning throughout the Screening outpatient portion of the study.
13.The subject is willing to remain in bed for at least 6.5 hours each night during the entire study.
14.Based on sleep history, the subject uses pharmacological assistance to sleep 0 to 4 (maximum allowable) times per week in the last 3 months. Subjects must agree to discontinue the use of all pharmacological sleep aids beginning 1 week prior to the first dose of single-blind study medication and throughout the entire duration of the study.
15.The subject must have a valid driving licence for at least 3 years and a reported history of having driven at least 5000 km per year on average, for the last 3 years prior to entering into the trial.
16.The subject has normal static binocular acuity, corrected or uncorrected.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
1.The subject has a known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.
2.The subject has a known hypersensitivity to zopiclone or related compounds.
3.The subject has received any investigational compound within 30 days or 5 half-lives prior to the first dose of single-blind study medication, whichever is longer.
4.The subject has received ramelteon in a previous clinical study or as a therapeutic agent.
5.The subject has donated more than 400 mL of blood within the 90 days preceding the beginning of the study.
6.The subject has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of single-blind study medication.
7.The subject has flown across greater than 3 time zones within 7 days prior to Screening, or will travel across 2 or more time zones during the course of the study.
8.The subject has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first night of single-blind study medication.
9.The subject has a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, severe COPD, fibromyalgia.
10.The subject has a history of psychiatric disorder (including anxiety, depression, mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the past 6 months.
11.The subject has a history of drug addiction or drug abuse within the past 12 months as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised (DSM-IV-TR).
12.The subject has a history of alcohol abuse within the past 12 months, as defined in DSM-IV-TR, or regularly consumes more than 21 alcoholic units per week, and does not agree to abstain from consuming any alcoholic drinks within 24 hours of all inpatient visits.
13.The subject has a current significant neurological (including cognitive and psychiatric disorder), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication.
14.The subject uses tobacco products (including nicotine gum and patch) or any other products during nightly awakenings that may interfere with the sleep wake cycle.
15.The subject has a positive urine drug screen at the Screening Visit or breathalyzer test at Visit 4.
NOTE: Subjects with positive urine drug screen for legal substances at Screening, or a positive breathalyzer test at Visit 4, where a washout is possible must be approved by both the sponsor and the principal investigator.
16.Subjects who exhibit a placebo response during single-blind placebo run in period. A placebo response is defined as those subjects that have an average change in sSL >20 minutes as calculated from the reported PSQ/ IVRS information [Appendix H].
17.The subject has used any central nervous system medication, melatonin or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first day of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
18.The subject intends to continue taking any disallowed medication or any prescription medication or over-the-counter (OTC) medication that is known to affect the sleep/wake func
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method