Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ramelteon · 12 trials · 6 indications
The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).
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 8 mg QD | EXPERIMENTAL | - |
| Zopiclone 7.5 mg QD | ACTIVE_COMPARATOR | - |
| Placebo QD | PLACEBO_COMPARATOR | - |
| Ramelteon 16 mg QD | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Ramelteon 4 mg QD | EXPERIMENTAL | - |
| Ramelteon 1 mg QD | EXPERIMENTAL | - |
| Ramelteon 2 mg QD | EXPERIMENTAL | - |
| 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 8 mg, tablets, orally, once daily for up to 28 nights. |
| Zopiclone | DRUG | Zopiclone 7.5 mg, tablets, orally, once daily for up to 28 nights. |
| Placebo | DRUG | Placebo-matching tablets, orally, once daily for up to 28 nights. |
| Ramelteon 8 mg | DRUG | - |
| Zopiclone 7.5 mg | DRUG | - |
Inclusion Criteria: * Men or women aged 18 to 64 years, inclusive. * Capable of understanding and willing to comply with the protocol and had to fully understand and sign the informed consent document at screening prior to any study-related procedures being performed. In addition, subjects had to ...
Ramelteon is an investigational small molecule being developed for sleep-related conditions, including transient insomnia, chronic insomnia, sleep initiation and maintenance disorders, and circadian rhythm sleep disorders. It has been studied in Phase 2 and Phase 3 clinical trials for these indications.
Ramelteon is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has conducted multiple clinical trials for the drug across various countries, including the United States, Australia, and several European nations.
Ramelteon has completed Phase 3 clinical trials for chronic insomnia, with a total of five trials completed and no active trials currently ongoing. The drug remains investigational and has not been reported as FDA approved based on the available clinical trial data.
Ramelteon has been studied in five completed trials, including NCT00247390, a Phase 3 study in adults with chronic insomnia, and NCT00325728, a Phase 2 trial in subjects with mild to moderate Alzheimer's disease. Other trials include NCT00593736 for delayed sleep phase syndrome and NCT00671190 in healthy subjects.
Ramelteon is also known by the brand name Rozerem, which is a melatonin receptor agonist used for insomnia. The clinical trials listed for Ramelteon, such as NCT00247390, evaluate the drug's efficacy and safety in conditions like chronic insomnia and circadian rhythm disorders.