Multi center, double blind, randomized, placebo controlled, active reference, parallel group polysomnography study to assess the efficacy and safety of a 16 day oral administration of ACT 078573 in adult subjects with chronic primary insomnia.

Actelion Pharmaceuticals Ltd0 sites668 target enrollmentMay 9, 2008

Overview

No summary available.

Registry

who.int

Start Date

May 9, 2008

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 \< 1% per year (such as implants, injectables, combined oral hormonal contraceptives, some intrauterine devices), sexual abstinence, or vasectomised partner.
•Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea at least 1 year), or surgically or naturally sterile.
•3\. Body mass index \=18\.5 and \< 32 kg/m2\.
•4\. Primary insomnia by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM IV TR®) criteria.
•5\. Self reported history of the following for at least 3 months prior to the screening visit:
•\- Usual time to fall asleep \= 30 min
•\- Usual wake time during sleep \= 30 min
•\- Usual total sleep time \< 6\.5 h.

•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.