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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00770692 | A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150) | PHASE3 | COMPLETED | 369 | — | — | Oct 1, 2008 | May 1, 2010 | Nov 22, 2012 | 34 | Japan |
Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)\*100. An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF.
| Arm | Type | Description |
|---|---|---|
| Eszopiclone 1 mg- Elderly | EXPERIMENTAL | - |
| Eszopiclone 2 mg- Elderly | EXPERIMENTAL | - |
| Eszopiclone 2 mg- Non-elderly | EXPERIMENTAL | - |
| Eszopiclone 3 mg- Non-elderly | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Eszopiclone 1 mg- Elderly | DRUG | Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment. |
| Eszopiclone 2 mg- Elderly | DRUG | Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment. |
| Eszopiclone 3 mg- Non-elderly | DRUG | Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment. |
| Eszopiclone 2 mg- Non-elderly | DRUG | Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment. |
Inclusion criteria: 1. Participants who submit written informed consent for study entry. 2. Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent. 3. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 3 | PHASE3 | Tasimelteon |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Suvorexant |
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan , Astra-Zeneca |
| Unity Health Toronto | UBX | 1 | PHASE2 | Lemborexant |
| ResMed Inc. | RMD | 1 | NA | Undisclosed |
| IQVIA Holdings Inc | IQV | 1 | — | Daridorexant, Non-orexin receptor antagonist medications for insomnia |