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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00656994 | Long-Term Efficacy of Ramelteon on Endocrine Function in Adult Subjects With Chronic Insomnia | PHASE3 | COMPLETED | 122 | — | — | Jan 1, 2003 | Jul 1, 2004 | Feb 28, 2012 | 29 | United States |
| NCT00319215 | Effects of Ramelteon on Driving Ability | PHASE1 | COMPLETED | 30 | — | — | Mar 1, 2006 | Jul 1, 2006 | Apr 25, 2007 | 1 | Netherlands |
| NCT00914862 | Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults | PHASE1 | COMPLETED | 56 | — | — | Nov 1, 2009 | Apr 1, 2011 | Apr 4, 2012 | 2 | United States |
Maximum observed serum concentration (Cmax) is the peak serum concentration of ramelteon and its metabolite (M-II) after administration, obtained directly from the serum concentration-time curve.
Tmax: Time to reach the maximum serum concentration (Cmax) of ramelteon and its metabolite M-II, equal to time (hours) to Cmax.
Area under the serum concentration-time curve from time 0 to time of last quantifiable concentration (tlqc) of ramelteon and its metabolite M-II, calculated using the linear trapezoidal rule.
Area under the serum concentration-time curve from time zero extrapolated to infinity for ramelteon and its metabolite M-II. The terminal area from the last quantifiable concentration (lqc) to infinity is calculated by approximation: lqc / terminal elimination rate constant (λz).
Apparent oral clearance of drug from the serum calculated as: CL/F = Dose / Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC\[0-inf\]).
The rate at which ramelteon and its metabolite M-II are eliminated from the body, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.
Terminal phase elimination half-life (T1/2) for ramelteon and its metabolite M-II is the time required for half of the drug to be eliminated from the serum, calculated as T1/2 = natural logarithm of 2 (ln\[2\]) / Terminal elimination rate constant (λz).
Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as Vz/F = Apparent oral clearance (CL/F) / Terminal elimination rate constant (λz).
| Arm | Type | Description |
|---|---|---|
| Ramelteon 16 mg QD | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Children Ramelteon 4 mg | EXPERIMENTAL | Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon. |
| Children Ramelteon 8 mg | EXPERIMENTAL | Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon. |
| Adolescents Ramelteon 4 mg | EXPERIMENTAL | Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon. |
| Adolescents Ramelteon 8 mg | EXPERIMENTAL | Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon. |
| Healthy Adult Ramelteon 8 mg | ACTIVE_COMPARATOR | Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon. |
| Name | Type | Description |
|---|---|---|
| Ramelteon | DRUG | Ramelteon 16 mg, tablets, orally, once nightly for up to 6 months. |
| Placebo | DRUG | Ramelteon placebo-matching tablets, orally, once nightly for up to 6 months |
| Ramelteon 8 mg | DRUG | - |
| Zopiclone 7.5 mg | DRUG | - |
Inclusion Criteria * Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. * Has had primary insomnia as defined by the Diagnostic and Statistical Manual of 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 |