Age range studied

“Eligible participants were adults (aged 18-55 years) with a primary diagnosis of schizophrenia” (opens the source at this quote in a new tab)

“18 Years to 65 Years (Adult, Older Adult )” (opens the source at this quote in a new tab)

“Healthy adult male and female subjects between 18 to 55 years of age inclusive at the screening visit.” (opens the source at this quote in a new tab)

Sex and race of NOVA-1 participants

“There were 359 participants randomized (mean [SD] age, 39.1 [9.3] years; 69 female [19.2%]; 290 male [80.8%]” (opens the source at this quote in a new tab)
“Many sites had a trial population that was predominantly Black, reflecting the urban US clinical settings in which recruitment for many sites occurred.” (opens the source at this quote in a new tab)

Renal impairment: NOVA-1 exclusion criteria

“Creatinine ≥2 mg/dL or ≥176.8 μmol/L” (opens the source at this quote in a new tab)
“Estimated creatinine clearance of <45 mL/min, calculated using the Cockcroft-Gault equation, at Screening” (opens the source at this quote in a new tab)

Hepatic impairment: NOVA-1 exclusion criteria

“AST >2 × ULN” (opens the source at this quote in a new tab)
“ALT >2 × ULN” (opens the source at this quote in a new tab)
“Patients with chronic hepatitis B or hepatitis C may be included after discussion with the Medical Monitor provided that their condition is stable and values for liver function test meet the specified criteria of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2 × upper limit of normal (ULN).” (opens the source at this quote in a new tab)

Cardiac conduction and cardiovascular disease: NOVA-1 exclusion criteria

“Interval between Q and T wave corrected for heart rate using Fridericia’s formula (QTcF) interval >450 msec for males and females” (opens the source at this quote in a new tab)
“PR interval ≥200 msec” (opens the source at this quote in a new tab)
“Intraventricular conduction delay with QRS duration >120 msec” (opens the source at this quote in a new tab)
“Patients with known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery.” (opens the source at this quote in a new tab)

Cardiac conduction: PET study exclusion criteria

“The subject has a history of QT prolongation or dysrhythmia or a family history of prolonged QT interval or sudden death.” (opens the source at this quote in a new tab)
“QTcF interval > 450 msec for males and females” (opens the source at this quote in a new tab)

Medical exclusions in NOVA-2

“Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery” (opens the source at this quote in a new tab)
“History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the patient” (opens the source at this quote in a new tab)
“Insulin dependent diabetes” (opens the source at this quote in a new tab)

Medical exclusions in NOVA-3

“History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other” (opens the source at this quote in a new tab)

Pregnancy, lactation, and contraception

“The effect of LB-102 on pregnant women and fetal development is unknown.” (opens the source at this quote in a new tab)
“Females who are breastfeeding or who have a positive pregnancy test result prior to receiving trial medication.” (opens the source at this quote in a new tab)
“Sexually active females of childbearing potential and male patients who are not practicing 2 different methods of birth control with their partner during the trial and for 30 days after the last dose of trial medication or who would not remain abstinent during the trial and for 30 days after the last dose.” (opens the source at this quote in a new tab)
“Male patients or male partners of female patients should not donate sperm until 90 calendar days after the last dose of study drug.” (opens the source at this quote in a new tab)

“Sexually active m/f not willing to adhere to highly effect birth control” (opens the source at this quote in a new tab)
“Breast feeding” (opens the source at this quote in a new tab)

“Sexually active M/F patients not willing to use highly effective contraception” (opens the source at this quote in a new tab)

Suicidality: exclusion criteria

“Risk for suicidal behavior during the study as determined by the Investigator’s clinical assessment and Columbia-Suicide Severity Rating Scale (C-SSRS)” (opens the source at this quote in a new tab)
“on items 4 or 5 (C-SSRS – Ideation) with the most recent episode occurring within the 6 months before Screening” (opens the source at this quote in a new tab)
“to any of the 5 items (C-SSRS – Suicidal Behavior) with an episode occurring within the 12 months before Screening” (opens the source at this quote in a new tab)

“Risk of suicidal behavior” (opens the source at this quote in a new tab)

Substance use: exclusion criteria and restrictions

“Patients who met DSM-5 criteria for substance abuse or dependence within the past 1 year, including alcohol and benzodiazepines, but excluding caffeine and nicotine.” (opens the source at this quote in a new tab)
“subjects are required to abstain from alcohol and cannabis use during the trial” (opens the source at this quote in a new tab)
“Smoking is allowed, under supervision.” (opens the source at this quote in a new tab)

Other excluded groups in NOVA-1

“Patients who presented with a first episode of schizophrenia based on the clinical judgment of the Investigator and patients with diagnosed schizophrenia equal to or less than a year.” (opens the source at this quote in a new tab)
“History of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (dose and duration as per the label) or required clozapine within the last 12 months.” (opens the source at this quote in a new tab)
“Patients with insulin-dependent diabetes mellitus (i.e., any patients using insulin) are excluded.” (opens the source at this quote in a new tab)
“Patients with epilepsy or a history of seizures (with the exception of febrile seizure).” (opens the source at this quote in a new tab)
“Patients with a history of neuroleptic malignant syndrome.” (opens the source at this quote in a new tab)

Planned study in elderly healthy volunteers

“Elderly HV Phase 1 trial (safety / PK)” (opens the source at this quote in a new tab)

Class context: amisulpride in renal impairment

“In renal insufficiency, the dose should be reduced to half in patients with creatinine clearance (CRCL) between 30-60 ml/min and to a third in patients with CRCL between 10-30 ml/min.” (opens the source at this quote in a new tab)
“The AUC of amisulpride in mild renal failure increased two fold and almost tenfold in moderate renal failure (see section 4.2).” (opens the source at this quote in a new tab)

“In subjects with severe renal impairment (eGFR < 30 mL/min/1.73 m2) and no requirement for dialysis, the Cmax of amisulpride after a single 10 mg intravenous dose was not greater than that in healthy subjects with normal renal function, and the AUC(0-∞) was approximately twice as high.” (opens the source at this quote in a new tab)

Class context: amisulpride in hepatic impairment, elderly patients, children, and lactation

“Hepatic insufficiency: since the drug is weakly metabolised a dosage reduction should not be necessary in patients with hepatic insufficiency.” (opens the source at this quote in a new tab)
“Limited pharmacokinetic data in elderly subjects (> 65 years) show that a 10-30 % rise occurs in Cmax, T1/2 and AUC after a single oral dose of 50 mg.” (opens the source at this quote in a new tab)
“Therefore, the use of amisulpiride from puberty to the age of 18 years is not recommended; in children up to puberty amisulpride is contraindicated, as its safety has not yet been established.” (opens the source at this quote in a new tab)

“Based on case reports in published literature, amisulpride is present in human milk at concentrations that are 11- to 20-fold higher than human plasma in patients taking multiple oral doses of amisulpride (200 to 400 mg/day).” (opens the source at this quote in a new tab)

QTc and laboratory exclusion thresholds in NOVA-2 and NOVA-3

No evidence found.

Renal impairment study, hepatic impairment study, pediatric data, and data in adults older than 65 years for LB-102

No evidence found.