Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Iloperidone · 8 trials · 5 indications
As measured by the time to first exacerbation of psychiatric symptoms
The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst).
Relapse or impending relapse was defined as any of the following: hospitalization due to worsening of schizophrenia; increase (worsening) of the PANSS total score of greater than or equal to 30% from randomization, PANSS total score confirmed at a second visit conducted within 1-7 days; clinically significant emergent or worsening suicidal, homicidal, or aggressive behavior; a CGI-Improvement (CGI-I) score of 6 (much worse) or 7 (very much worse) after randomization; a dose increase in study medication or a need for additional open-label antipsychotic treatment.
The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.
As measured by plasma concentrations.
As measured by spontaneous reporting of adverse events (AEs).
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing. From the plasma concentration data, AUC, Cmax ss, and Tmax ss are calculated.
Frequency of treatment emergent adverse events, frequency of clinically notable changes from baseline in vital signs, electrocardiograms, laboratory tests, and reponses on movement disorder rating scales (Barnes Akathisia Rating Scale, Simpson-Angus Scale) and on a rating scale for suicidal thoughts and behaviors (Columbia Suicide Severity Rating Scale)
| Arm | Type | Description |
|---|---|---|
| iloperidone | EXPERIMENTAL | During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (iloperidone long-acting injection) as long-acting intramuscular injections for up to 52 weeks. |
| placebo | PLACEBO_COMPARATOR | During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (matching placebo) as long-acting intramuscular injections for up to 52 weeks. |
| Ziprasidone | ACTIVE_COMPARATOR | Oral ziprasidone |
| Experimental/Iloperidone | EXPERIMENTAL | - |
| Placebo Comparator | PLACEBO_COMPARATOR | - |
| CYP2D6 non-poor metabolizers | OTHER | titrated up to 24 mg daily (12 mg b.i.d.) |
| CYP2D6 poor metabolizers | OTHER | titrated up to 12 mg daily (6 mg b.i.d.) |
| Name | Type | Description |
|---|---|---|
| iloperidone | DRUG | iloperidone LAI |
| placebo | DRUG | matching placebo |
| Iloperidone Placebo | DRUG | Oral placebo |
| Ziprasidone | DRUG | - |
| iloperidone (oral tablet) | DRUG | iloperidone 12 to 24 mg/day followed by 26 weeks of flexible dosing (6 to 24 mg/day) |
Inclusion Criteria: * Males or females 18 to 65 years of age (inclusive) * Diagnosed with schizophrenia per DSM-5 criteria * In need of ongoing psychiatric treatment Exclusion Criteria: * DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment wi...