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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03375203 | A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder | PHASE2 | COMPLETED | 365 | — | — | Nov 23, 2017 | Apr 3, 2019 | Apr 29, 2025 | 56 | United States, Belgium +4 |
Change in LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to JNJ-42847922 as oral capsules at normal study bedtime on Nights 1 through 14. |
| JNJ-42847922 5 milligram (mg) | EXPERIMENTAL | Participant will receive JNJ-42847922 5 mg dose as oral capsules at normal study bedtime on Nights 1 through 14. |
| JNJ-42847922 10 mg plus Placebo | EXPERIMENTAL | Participant will receive JNJ-42847922 10 mg as oral capsule and one placebo capsule at normal study bedtime on Nights 1 through 14. |
| JNJ-42847922 20 mg plus Placebo | EXPERIMENTAL | Participant will receive JNJ-42847922 20 mg as oral capsule and one placebo capsule at normal study bedtime on Nights 1 through 14. |
| Zolpidem plus Placebo | EXPERIMENTAL | Participants will receive Zolpidem 5 mg plus one placebo capsule or 10 mg dose as oral capsule at normal study bedtime on Nights 1 through 14. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Matching placebo will be administered once daily based upon dosing group. |
| JNJ-42847922, 5 mg | DRUG | JNJ-42847922 will be administered as 5 mg (2\*2.5 mg capsule) oral capsules once daily. |
| JNJ-42847922, 10 mg | DRUG | JNJ-42847922 will be administered as 10 mg oral capsule once daily. |
| JNJ-42847922, 20 mg | DRUG | JNJ-42847922 will be administered as 20 mg oral capsule once daily. |
| Zolpidem | DRUG | Zolpidem will be administered as 5 mg or 10 mg (2\*5mg capsule) oral capsule once daily based upon the local labeling information. |
Inclusion Criteria: * Participant must be a man or women of non-childbearing potential (WONCBP), 18 to 85 years of age, inclusive, on the day of signing informed consent. A WONCBP is defined as: a).Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative m...
| 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 |