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.

• Conditions: Chronic primary insomnia; MedDRA version: 9.1Level: LLTClassification code 10022437Term: Insomnia

• Registration Number: EUCTR2007-005194-56-DK
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-10
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 668

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 < 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.
confirmed on at least 3 nights (out of 7 consecutive nights prior to Visit 2) on the screening Sleep Diary.
6. Usual bedtime between 20:00 and 01:00
confirmed on at least 5 nights (out of 7 consecutive nights prior to Visit 2) on the screening Sleep Diary.
7. Mean LPS = 20 min (with no night < 15 min), mean WASO = 20 min (with no night < 15 min), and mean TST < 420 min on the 2 PSG screening nights.
8. Ability to communicate well with the investigator, and to understand the study requirements.

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) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified