A randomized, double-blind, placebo-controlled, crossover study to evaluate the effects of morning administration of GW679769 (10mg and 30 mg) on polysomnograph sleep recordings, subjective sleep assessment, daytime cognition and psychomotor function in subjects with primary insomnia. - N/A

• Conditions: Primary insomnia

• Registration Number: EUCTR2005-004889-17-DE
• Lead Sponsor: GlaxoSmithKline Research and Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Able to read and understand the informed consent form and provide written informed consent, indicating understanding of the purpose of the study and willingness to comply with all study procedures described in the protocol, including all sleep-laboratory restrictions and procedures.
2. Male or female between the ages of 18 and 64 years (inclusive).
3. Has a principal diagnosis of primary insomnia, based on Diagnostic and Statistical Manual of Mental Disorders-Text Revision (DSM-IV-TR) criteria 307.42: (please refer to protocol).
4. The self-reported sleep history over the preceding three months indicates:
• a usual total sleep time (TST) of less than six hours, sleep onset latency (SOL) of at least 30 minutes and at least two awakenings per night in at least three nights per week.
• a time in bed between 6.5 and 8.5 hours for at least five nights per week .
• bed time between 21.00 and 24.00 hours that does not vary by more than ±2 hour. Bedtime (lights out) will be confirmed by a one week diary completed before the first polysomnography (PSG) screening session.
5. The sleep variables obtained from the two Screening PSGs (with single-blinded placebo administration each morning) must fall within the protocol-defined ranges.
6. Women of childbearing potential must commit to consistent and correct use of an acceptable method of birth control; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:
1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses)
2. Child-bearing potential, has a negative serum pregnancy test result at the Screening Visit and negative urine dipstick pregnancy tests at the screening PSG session (Visit 2) and prior to randomization at Visit 4, and agrees to one of the following:
• Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
• Oral contraceptives (either combined or progestogen only) with double barrier method of contraception consisting of spermicide with either condom or diaphragm throughout the clinical trial, and for six weeks following the last dose of study medication.
• Double-barrier method of contraception consisting of spermicide with either condom or diaphragm
• IUD with a documented failure rate of less than 1% per year
• Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of three days, equivalent to five half lives).
- If subjects indicate they will remain abstinent during the period described above, they must agree to follow GSK guidelines for the consistent and correct use of an acceptable method of birth control should they become sexually active.
7. Is in good health as determined by medical and psychiatric history, physical examination, ECG, and serum chemistry, hematology, serology, and urinalysis results.
8. Subjects with a history of peptic ulcer disease (PUD) with a known etiology must provide documentation by a gastroenterologist of the etiology of the PUD and that effective treatment was provided with full eradication of ulcers and symptoms. For such subjects appropriate steps must also have b

Exclusion Criteria

1. Symptoms/signs that are consistent with any primary sleep disorder other than primary insomnia. 2. Any clinically significant psychiatric disorder other than primary insomnia as defined by DSM-IV-TR. 3. A recent history (12 months) of mood of other mental disorders that the investigator regards as accounting for the insomnia.
4. A Beck Depression Inventory (version II) total score of 29 or greater. Subjects scoring 17 to 28 must be confirmed to not have major depressive illness.
5. History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence (with the exception of tobacco) within 12 months as defined by DSM-IV-TR. 6. Positive urine drug screen at Screening Visit. 7. Alcohol breath test positive for the ingestion of alcohol at the Screening Visit. 8. Any history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (including febrile seizure). 9. An unstable medical disorder or a disorder that would likely interfere with the ADME of GW679769, may pose a safety concern or interfere with accurate assessment of efficacy and safety. 10. Has active peptic ulcer disease (PUD) and/or history of PUD of an unknown etiology. 11. Likely to require the use of the following medications: • NSAIDs: use of an NSAID (this includes aspirin) is only permitted when administered concomitantly with an anti-secretory agent i.e., proton-pump inhibitor or histamine-2 receptor antagonist. • concomitant use of aspirin at any dose and NSAIDS including COX2 inhibitors. 12. Has a stool positive for occult blood. If such a stool was obtained without the subject abstaining from red meat for three or more days prior, testing may be repeated once following such abstinence.
13. Has a history of myopathy or rhabdomyolysis. 14. Any serious medical disorder or condition that would in the Investigator's opinion, preclude the administration of study medication. 15. Has any screening electrocardiography (ECG) parameter outside of the Sponsor-specified ranges as determined by a central ECG reader; the ECG may be repeated once to see if the parameter returns to within range but any such abnormality must be resolved by the first day of the screening PSG session.
16. Has any ECG finding that in the investigator's judgement is considered to be clinically significant and not resolved by the first day of the screening PSG session .
17. Known seropositivity for human immunodeficiency virus (HIV), or active Hepatitis B, or Hepatitis C infection. 18. Women having a positive serum HCG pregnancy test at Screening Visit, a positive urine pregnancy dipstick during the screening PSG Session or at randomization, or who are lactating or planning to become pregnant within the three months following the Screening Visit. 19. Has any laboratory value outside of the Sponsor-specified ranges at the Screening Visit. With the exception of troponin I, testing may be repeated once to see if value returns to within range but any such laboratory abnormality must be resolved by the first day of the screening PSG session (visit 2).Testing can not be repeated if the troponin I value is above the sponsor-specified limit (0.3ng/ml) and the subject should be referred to the treating physician for further evaluation as appropriate. 20. Has any laboratory abnormality that in the investigator's judgment is considered to be clinically significant and not resolved by the

Study & Design

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