Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GR205171 · 1 trial · 1 indication
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-...
GR205171 is an investigational small molecule being studied for the treatment of Sleep Initiation and Maintenance Disorders, a condition also known as primary insomnia. It is being developed as a potential new drug for this psychiatric condition, though it remains in clinical development and is not yet approved.
GR205171 is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The company has conducted clinical research on this investigational drug for the treatment of sleep initiation and maintenance disorders.
GR205171 is in Phase 2 clinical development. It has completed one Phase 2 trial for Sleep Initiation and Maintenance Disorders, with a total of 51 participants enrolled. The drug is investigational and has not been approved by regulatory authorities.
GR205171 has one completed clinical trial, registered as NCT00606697, titled "A Study With GW597599 And GR205171: Potential New Drugs For The Treatment Of Primary Insomnia." This Phase 2 study enrolled 51 participants in Germany and was an active-controlled, randomized trial.
No, GR205171 is not the same as GW597599. These are two distinct investigational drugs that were studied together in the same clinical trial, NCT00606697, for the treatment of primary insomnia. The trial evaluated both compounds as potential new treatments for this condition.