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About
The aim of the study is to determine the minimum effective dose of ACT-078573 on sleep efficiency and to assess the effects of different doses of ACT-078573 on other PSG parameters.
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Inclusion criteria
Reliable methods of contraception are:
Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
Intra-uterine devices.
Oral, injectable, implantable or transdermal contraceptives only in combination with a barrier method.
Women not of childbearing potential are defined as prepubescent, postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
Body mass index (BMI) between 18 and 30 kg/m2 (limits included) at screening visit.
12-lead ECG without clinically relevant abnormalities at screening visit.
Hematology and biochemistry test results not deviating from the normal range to a clinically relevant extent at screening visit and following the screening/adaptation night.
Primary insomnia by DSM-IV-TR criteria based on medical history and the assessments performed at screening visit.
History of the following for at least 3 months prior to the screening visit:
Polysomnography (PSG) at screening/adaptation night confirming TST < 6 h and LPS ≥ 20 min.
Willingness to refrain from CNS-active drugs for 5 half-lives of the respective drug (but at least 1 week) prior to the screening/adaptation night and up to the end of treatment period 2. The usage of short-acting hypnotics (defined as hypnotics with a half-life of up to and including 10 hours) is allowed up to 48 hours prior to each PSG night, i.e., prior to the screening/adaptation night and prior to the treatment PSG nights.
Urine drug test negative for barbiturates, cannabinoids, amphetamines, and cocaine at screening visit 1, screening/adaptation PSG night and pre-treatment. Urine drug test negative for benzodiazepines and opiates at screening/adaptation PSG night and pre-treatment.
Signed informed consent prior to any study-mandated procedure.
Exclusion criteria
Symptom assessment questionnaire (SBB) for diagnosis of apnea resulting in a score > 2 at screening visit.
Zung self-rating depression scale (SDS) and/or Zung self-rating anxiety scale (SAS) resulting in a raw score ≥ 50 at screening visit.
Restless legs syndrome and/or meeting all four essential diagnostic criteria for RLS (see Appendix 10).
Insomnia due to sleep apnea or periodic limb movement disorder as assessed by PSG at screening/adaptation night:
Major depressive disorder, severe psychosis, or significant anxiety disorder.
Pregnancy or breast-feeding.
Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg at screening visit.
Within the 2-month period prior to the screening visit, clinical evidence of alcoholism or drug abuse.
Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease or a disease which may affect the pharmacokinetics of the study drug.
Treatment with strong inhibitors of CYP3A4 (e.g., azole derivatives, ritonavir, clarithromycin) within 1 week prior to the screening/adaptation PSG night and up to the end of treatment period 2.
Excessive caffeine consumption (regular caffeine consumption of > 7 units per day).
Night shift workers.
Known hypersensitivity to any excipients of the drug formulation.
Planned treatment or treatment with another investigational drug within 1 month prior to randomization and up to the end of treatment period 2.
Known concomitant life-threatening disease with a life expectancy < 24 months.
Unstable medical abnormality, significant medical disorder or acute illness.
Recruitment of the same patient twice to the same dose level. Patients may be recruited to a lower dose level, provided that there are at least 28 days between last study drug administration and screening/adaptation PSG night.
Primary purpose
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Interventional model
Masking
161 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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