Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00606697 | A Study With GW597599 And GR205171: Potential New Drugs For The Treatment Of Primary Insomnia | PHASE2 | COMPLETED | 51 | — | — | Dec 19, 2007 | May 7, 2008 | Jul 11, 2017 | 10 | Germany |
TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. The score was derived by a central polysomnography (PSG) reader and was analyzed as the mean of the PSG TST recordings obtained on two consecutive nights. If only one assessment was present for a particular PSG session, the score from that one assessment was used.
LPS was defined as the amount of time measured in minutes it takes to fall asleep as the point at which 10 minutes of uninterrupted sleep has begun as determined based on PSG objective assessments of sleep disturbance. PSG recording was performed. The score was derived by a central polysomnography reader and was analyzed as the mean of the PSG TST recordings obtained on two consecutive nights. If only one assessment was present for a particular PSG session, the score from that one assessment was used.
WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 minute) scored as non-wake. Mean values were calculated based on 2 treatment PSG nights. The score was derived by a central polysomnography reader and was analyzed as the mean of the PSG TST recordings obtained on two consecutive nights. If only one assessment was present for a particular PSG session, the score from that one assessment was used.
| Arm | Type | Description |
|---|---|---|
| Overall study | ACTIVE_COMPARATOR | Male and female subjects, 18-64 years of age (inclusive), with a primary diagnosis of primary insomnia |
| Name | Type | Description |
|---|---|---|
| GR205171 | DRUG | 10 milligrams (mg) |
| GW597599 | DRUG | 15 mg |
Inclusion Criteria: * The subject must be able to read and understand the informed consent form and provide written informed consent, indicating the subjects understanding of the purpose of the study and willingness to comply with all study procedures described in the protocol, including all sleep-...