Chronic primary insomnia MedDRA version: 9.1 Level: LLT Classification code 10022437 Term: Insomnia
Conditions
Interventions
Product Name: ACT-078573
Product Code: ACT-078573
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ACT-078573
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Actelion Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any study mandated procedure. 2. Male or female aged 18–64 years (inclusive) at screening. • Women of childbearing potential must have negative pregnancy tests before randomization and consistently and correctly use (from screening, during the entire study, and for at least 1 month after study drug intake) a reliable method of contraception with a failure rate of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. History of any sleep disorder other than primary insomnia. b. Any axis I disorder other than primary insomnia according to the DSM IV TR® criteria within 6 months prior to the screening visit. c. Apnea / hypopnea index (AHI) = 10/h on the first PSG screening night. d. Apnea or hypopnea event associated with oxygen saturation by pulse oximetry (SpO2) < 80%, on the first PSG screening night. e. Periodic limb movement arousal index (PLMAI) = 10/h on the first PSG screening night. f. Usual daytime napping = 1 hour per day, and = 3 days per week. g. Important caffeine consumption (= 500 mg per day). h. Pregnancy or breast feeding. i. Shift work within 3 months prior to the screening visit, planned shift work during study, travel = 3 time zones within 1 week prior to the screening visit, planned travel = 3 time zones during study, or history of circadian rhythm disorders. j. Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent. k. Alcohol or drug abuse within 1 year prior to the screening visit, or inability to refrain from drinking alcohol for at least 3 consecutive days. l. Positive drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or positive alcohol test on the evening of the PSG screening nights. m. Inability to refrain from smoking for at least 14 hours during the night. n. Unstable medical condition, significant medical disorder within 1 month prior to the screening visit or acute illness at the screening visit. o. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements. p. Treatment with Cognitive Behavioral Therapy (CBT) within 1 week prior to the first day of completion of the screening Sleep Diary. q. Unwillingness to refrain from prohibited CNS active drugs (see Appendix 2) for 5 half lives of the respective drug (but at least 1 week) prior to the first day of completion of the screening Sleep Diary, until 24 hours after the last administration of study treatment. r. Treatment with moderate or strong inhibitors of CYP3A4 (see Appendix 12) within 1 week prior to the first PSG screening night. s. Treatment containing simvastatin or lovastatin, at daily doses higher than 20 mg, within 1 day prior to the first PSG screening night. t. Known hypersensitivity or contraindication to drugs of the same class as the study treatment, or any excipients of the drug formulations, or to zolpidem. u. Treatment with another investigational drug within 1 month prior to the screening visit. v. Treatment with drugs metabolized by CYP2D6 isoenzyme with a narrow therapeutic index (see Appendix 12), within 1 day prior to the first PSG screening night.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate an effect of ACT 078573 at 200 mg at treatment start and at 16 days on a set of objective sleep-maintenance endpoints and over 2 weeks on subjective sleep-maintenance endpoint.;Secondary Objective: To demonstrate an effect of ACT 078573 • at 200 and 100 mg at treatment start and at 16 days on a set of objective endpoints (Sleep-Initiation, Total Sleep Time, Sleep Quality and delayed Word Recall Test) and over 2 weeks on a set of subjective endpoints (Sleep Initiation, Total Sleep Time, Sleep Quality and delayed Word Recall Test). • at 100 mg at treatment start and at 16 days on a set of objective Sleep Maintenance endpoints and over 2 weeks on a subjective Sleep Maintenance endpoint. Also included in the secondary objectives is an evaluation of the safety and tolerability of a 16-day oral administration of AC 078573 at doses of 200 and 100 mg. ;Primary end point(s): The change in sleep-maintenance as compared to pre treatment is chosen as the primary endpoint; it includes the following components: • Change from Baseline* to Day 1&2* in WASO. • Change from Baseline* to Day 15&16*in WASO. • Change from Baseline# to Week 1&2# in sWASO. * ‘Baseline’ is the mean of the 2 PSG screening nights. ‘Day 1&2’, ‘Day 15&16’ are the mean of the corresponding 2 PSG treatment nights. # ‘Baseline’ is the mean value of the screening Sleep Dairy entries at home between Visit 2 and 3. ‘Week 1&2’ is the mean value based on the Sleep Diary entries at home under double-blind study treatment (between Visit 3 and 4). WASO is the time spent awake after onset of persistent sleep (time spent in epochs scored as wake after onset of persistent sleep – see the definition of LPS) until ‘lights on’ as determined by PSG. sWASO is the self-reported time spent awake after sleep onset as reported in the Sleep Diary. Assumptions for sample size estimation: • a WASO difference of 20 min compared to placebo is to be detected. • normal distribution of the change from B | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed