NOVA-1: discontinuation and washout of prior antipsychotics

“Starting on the first day of the screening phase, after written informed consent for the study has been provided, all antipsychotic or other psychotropic medications will be stopped with clinically appropriate titration down as per the Investigator’s clinical judgment.” (opens the source at this quote in a new tab)
“The prohibited psychotropic agent must be discontinued and washed out at least 5 half-lives prior to Baseline.” (opens the source at this quote in a new tab)
“Subjects taking a depot antipsychotic could not have received a dose of medication for at least 1 and a half injection cycles before Baseline.” (opens the source at this quote in a new tab)
“Any patient unable to be safely discontinued from current antipsychotic therapy or other psychotropic medications will not be eligible for the study.” (opens the source at this quote in a new tab)

“Participants must have been free from antipsychotic treatment for 2 or more weeks (or ≥5 times the treatment half-life) before baseline assessment.” (opens the source at this quote in a new tab)

“Prior to initiating dosing, patients underwent a seven-day wash-out period, a length of time that an enrolled patient may not receive any treatment before they begin the trial.” (opens the source at this quote in a new tab)

NOVA-1: prohibited psychotropic medications

“Patients who are currently taking oral antipsychotic medications, monoamine oxidase inhibitors (MAOIs), anticonvulsants (e.g., lamotrigine, Depakote), tricyclic antidepressants (e.g., imipramine, desipramine), selective serotonin reuptake inhibitors, and any other antidepressants or any other psychoactive medications (except lorazepam, zolpidem, zaleplon, eszopiclone, or similar benzodiazepines, diphenhydramine, benztropine, and propranolol).” (opens the source at this quote in a new tab)
“The medications should not be discontinued solely to make the patient eligible for enrollment in the study.” (opens the source at this quote in a new tab)

NOVA-1: permitted rescue medications

“Psychotropic medications are prohibited except for lorazepam as needed for agitation, restlessness, irritability, or hostility; zolpidem, zaleplon, or eszopiclone for insomnia; diphenhydramine or benztropine for EPS; and propranolol for akathisia.” (opens the source at this quote in a new tab)
“every administration must be considered and approved by the Investigator prior to administration” (opens the source at this quote in a new tab)
“Allow nighttime use only (prn); exclude regular use; exclude daytime use; exclude use within 12 hours of a study visit” (opens the source at this quote in a new tab)
“During the End of Stabilization period, the use of lorazepam, benztropine, and propranolol is not restricted.” (opens the source at this quote in a new tab)

NOVA-1: dose limits for permitted rescue medications

Medication	Study period	Dose permitted
Lorazepam	Screening phase through day 7	“Maximum of 6 mg/day”
Lorazepam	Day 8 through day 14	“Maximum of 4 mg/day”
Lorazepam	Day 15 through day 28	“Maximum of 2 mg/day”
Benztropine	Screening phase through day 28	“Maximum 4 mg/day”
Propranolol	Screening phase through day 28	“Maximum of 40 mg/day”

NOVA-1: prohibited CYP2D6 inhibitors and CYP3A4 inhibitors and inducers

“Table 6.3 below provides a select list of CYP2D6 inhibitors and CYP3A4 inhibitors and inducers that are prohibited within 14 days of randomization and for the duration of the trial.” (opens the source at this quote in a new tab)

NOVA-1: electroconvulsive therapy and transcranial magnetic stimulation

“Patients who received electroconvulsive therapy within 90 days of Screening.” (opens the source at this quote in a new tab)
“Patients who received Transcranial Magnetic Stimulation (TMS) within 90 days of Screening.” (opens the source at this quote in a new tab)

NOVA-1: comorbid conditions at baseline

“The most common comorbid conditions at baseline were insomnia, anxiety, headache, depressive symptoms, and agitation” (opens the source at this quote in a new tab)

NOVA-1: unauthorized concomitant medications

“The inpatient setting minimized risks related to nonadherence, illicit substance use, and unauthorized concomitant medications; further studies are needed to assess whether these findings are generalizable to an outpatient population.” (opens the source at this quote in a new tab)

Phase 1: treatment of acute dystonia

“Subjects with moderate dystonia were treated with either Benadryl or Cogentin.” (opens the source at this quote in a new tab)

NOVA-3: prior oral antipsychotic treatment

“Taking oral antipsychotic treatment for at least 30 days” (opens the source at this quote in a new tab)
“who are experiencing inadequate response or who are having issues with side effects, general tolerability, or overall effectiveness of their current antipsychotic medication and desire to change medications, or who have completed their participation in current LB-102 clinical studies” (opens the source at this quote in a new tab)

Reported use of rescue and concomitant medications in NOVA-1

No evidence found.

Permitted and prohibited concomitant medications in NOVA-2 and NOVA-3

No evidence found.

Use of LB-102 in combination with another antipsychotic

No evidence found.