A Phase 4 interventional study of PERSERIS and Risperidone in Schizophrenia, sponsored by Indivior Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Indivior Inc. · Phase 4, Interventional, and Treatment
This study evaluates PERSERIS at a higher dose than what has been administered in previous clinical trials. Subjects with stable schizophrenia on a dose of 5-6 mg oral risperidone will be switched to PERSERIS at the higher dose, which is believed to be similar to the oral dose
PERSERIS is an extended-release subcutaneous (SC) injectable suspension administered monthly for the treatment of schizophrenia in adults. PERSERIS was approved by the FDA at doses equivalent to 3 mg and 4 mg oral risperidone. Many patients require doses of 5-6 mg oral risperidone and above, and this study will test a higher dose of PERSERIS in order to meet this need.
Eligible subjects will initially be stabilized in the clinical unit on 6 mg oral risperidone for 5 days and transition to an approximate dose of PERSERIS by SC injection. PERSERIS will be administered every 28 days and subjects will be admitted to the clinical unit the day before, and remain in the unit for 3 days after each injection for pharmacokinetics (PK) and safety evaluations (a total of 8 days for the first injection including the stabilization period). Subjects will return to the clinic between injections for additional PK, safety and efficacy assessments at scheduled intervals until the next injection.
A total of 4 doses of PERSERIS will be administered. The 4th dose will evaluate an alternate site for injection, and will be administered in the back of the upper arm.
Subjects will return to the clinical unit for an end of study visit and will receive a follow up phone call to assess for adverse events one week after the end of study visit.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 69 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Indivior Inc. is the lead sponsor of 51 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Taking the following concurrent or over the counter (OTC) products:
All subjects will receive 2 SC injections of PERSERIS at each study visit every 28 days for a total of 4 visits of 2 injections each. The first 3 visit injections will be administered in the abdomen and the final visit injections will be administered in the back of the upper arm.
Drug: PERSERIS · Drug: Risperidone
PERSERIS is an extended-release SC injectable suspension administered once-monthly
Also known as: long acting risperidone
Oral risperidone
Also known as: Risperdal
Steady-state Average Plasma Concentration (Cavg,ss) of Risperidone and Total Active Moiety
Cavg,ss for risperidone and total active moiety after oral and SC administration
Time frame: 0-12 hours post-dose on Day -1, and 0-672 hours after Dose 3
Assessment of Local Injection Site Tolerability*
Injection site tolerability was measured by injection site grading for redness, induration, swelling and tenderness/pain. These were graded on a scale from 0 to 4 for severity (none, mild, moderate, severe and potentially life-threatening)
Time frame: First injection at Day 1 until last injection administered at Day 85
The Number of Participants With TEAEs as Assessed by Local Injection Site*
The injection site was evaluated for adverse events by observation and examination by appropriately trained personnel.
Time frame: First injection at Day 1 until Day 120
The Number of Participants With TEAEs as Assessed by Changes in Vital Signs
Vital sign measurement was performed, including orthostatic blood pressure, and clinically significant changes were reported as adverse events (AE). Vital sign measurement also included measurement of pulse rate, oral temperature and respiratory rate. Determination of whether the changes were AEs was made by the investigator or a medically qualified designee. If determined to be an AE, the measurement was repeated at appropriate intervals until the value returned to an acceptable range and the subject was clinically stable, a specific diagnosis was established, or the condition otherwise explained.
Time frame: Time subjects sign the informed consent form throughout the study until EOS (Day 113)
The Number of Participants With TEAEs as Assessed by Changes in ECG
ECGs were performed, and clinically significant changes in parameters were reported as adverse events (AE). ECGs were performed after 5 minutes of rest, and ECG parameters including QT interval, PR interval, QRS interval and heart rate was recorded. The ECG measurements were evaluated during the visit and determination of whether any abnormalities were AEs was made by the investigator or a medically qualified designee. If determined to be an AE, the measurement was repeated at appropriate intervals until the value returned to an acceptable range and the subject was clinically stable, a specific diagnosis was established, or the condition otherwise explained.
Time frame: Time participants sign the informed consent form throughout the study until EOS (Day 113)
The Number of Participants With TEAEs as Assessed by Changes in Body Weight
Body weight, with shoes off, was measured and clinically significant changes in weight was reported as adverse events (AE). Determination of whether the changes were AEs was made by the investigator or a medically qualified designee. If determined to be an AE, the measurement was repeated at appropriate intervals until the value returned to an acceptable range and the subject was clinically stable, a specific diagnosis was established, or the condition otherwise explained.
Time frame: Time subjects sign the informed consent form throughout the study until EOS (Day 113)
The Number of Participants With TEAEs as Assessed by Changes in Laboratory Testing
Laboratory testing was performed by the local clinical laboratory accredited by the College of American Pathologists, and clinically significant changes from baseline were reported as AEs. Subjects were expected to fast for a minimum of 8 hours prior to blood draws for all laboratory assessments except at the screening visit. Prior to entering the study, any abnormal laboratory test results were to be considered not clinically significant. Any abnormal hematology, serum chemistry or urinalysis test result after study drug intake that was determined by the investigator or a medically qualified designee to be clinically significant was reported as an AE. If determined to be an AE, the measurement was repeated at appropriate intervals until the value returned to an acceptable range or it was determined that resolution was not expected.
Time frame: Time subjects sign the informed consent form throughout the study until end of study (EOS) visit (Day 113)
The Number of Participants With TEAEs as Assessed by Extrapyramidal Symptoms (EPS) of Anti-psychotic Drug Treatment
Safety of treatment was measured by administration of symptom questionnaires including AIMS, Barnes Akathisia Rating Scale (BARS) and Simpson-Angus Scale (SAS), as well as by assessment by the investigator or suitably qualified medical designee. The AIMS is a tool that aids in early detection and ongoing monitoring of tardive dyskinesia, a movement disorder. The BARS is a 4-item scale that detects the presence and severity of any drug-induced restlessness. The SAS is a 10-item scale used to detect the presence of drug-induced Parkinsonism (movement disorder seen in Parkinson's disease) and extrapyramidal side effects and evaluates symptom severity. Extrapyramidal symptoms include involuntary or uncontrollable movements, tremors, and muscle contractions.
Time frame: Time subjects sign the informed consent form throughout the study until EOS (Day 113)
Positive and Negative Syndrome Scale (PANSS)
Clinical outcome (efficacy endpoint) as measured by change from baseline in PANSS scores was measured. PANSS is a medical scale designed to measure schizophrenia symptom severity utilizing a 30 item, 7-point rating scheme. The PANSS Is scored by a summation of ratings across items, with a total potential range of 7-210; higher results indicate greater severity of illness. Only total score changes from baseline are reported here.
Time frame: Baseline, defined as last assessment prior to first injection, through Day 113 (EOS)
Clinical Global Impression-Severity of Illness Scale (CGI-S)
Clinical outcome (efficacy endpoint) as measured by change from baseline in CGI-S scores was measured. The CGI-S is a measurement of the total severity of illness where one question is assessed. Responses range from 0 (not assessed) to 7 (most extremely ill).
Time frame: Baseline through EOS (Day 113)
Columbia-Suicide Severity Rating Scale (C-SSRS)-Change
Significant changes from baseline in C-SSRS scores were reported as adverse events. The C-SSRS is based on a categorization of thoughts and behavior that are identified as related to suicidal behavior. The scale captures the occurrence, severity and frequency of suicide related thoughts and behaviors throughout lifetime at screening and for the time interval since last administration during a study. Responses are indicated as yes (thought or behavior did occur) or no (thought or behavior did not occur). If a yes response is received, then follow up questions are asked. The outcome of the C-SSRS is a numerical score obtained from each of the categories. Scores can range from 0-25, indicating the intensity rating, and any score greater than 0 may indicate the need for mental health intervention. Higher scores indicate greater intensity (i.e. worse outcome).
Time frame: Screening through EOS (Day 113)
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Safety of treatment was measured by characterization of thoughts and behavior related to suicidal behavior. This was assessed by administration of the C-SSRS at designated visits. The scale captures the occurrence, severity and frequency of suicide related thoughts and behaviours throughout lifetime at screening and for the time interval since last administration during a study. Questions solicit the type of information needed to determine if a suicide-related thought or behavior occurred.
Time frame: Screening through EOS (Day 113)
Minimum Plasma Concentration Over the Dosing Interval
Minimum observed plasma concentration of risperidone, 9-hydroxyrisperidone (9-OH) and total active moiety over the dosing interval after oral dosing and SC doses 1, 3 and 4
Time frame: Calculated over the dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4).
Maximum Plasma Concentration Over the Dosing Interval
Maximum observed plasma concentration of risperidone, 9-hydroxyrisperidone (9-OH) and total active moiety over the dosing interval after oral dosing and SC doses 1, 3 and 4
Time frame: Calculated over the dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4)
Percent Fluctuation in Concentration Over the Dosing Interval
Plasma concentration variation of risperidone, 9-OH and total active moiety over the dosing interval was measured by percent fluctuation after oral dosing and SC doses 1, 3 and 4 at steady state.
Time frame: Calculated over the dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4)
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
Area under the plasma concentration-time curve (AUC) was measured for risperidone, 9-OH and total active moiety.
Time frame: Calculated over the dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4).
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
Average plasma concentration of risperidone, 9-hydroxyrisperidone (9-OH) and total active moiety over the dosing interval after oral dosing and SC doses 1, 3 and 4.
Time frame: Calculated over the dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4).
Trough Plasma Concentration
Trough (pre-dose) plasma concentrations were measured for risperidone, 9-OH and total active moiety for SC doses 1, 3 and 4
Time frame: Calculated over the dosing interval (0-672 hours) after Dose 1, 3 or 4.
Time to Occurrence of Maximum Concentration
Time to maximal observed plasma concentration (Tmax) for risperidone, 9-OH, and total active moiety after oral dosing and SC doses 1, 3 and 4.
Time frame: Calculated over the overall dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4).
The study recruited participants from the community between June and December 2019. Participants were on a stable dose of 5 mg or 6 mg of oral risperidone daily; any daily or twice daily dosing combination was acceptable.
| Milestone | Oral Risperidone Followed by PERSERIS |
|---|---|
| Started | 69 |
| Stabilization period | 25 |
| Treatment period | 23 |
| Completed | 15 |
| Not completed | 54 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Physician decision | 2 |
| Withdrew: Did not pass screening criteria | 44 |
Cavg,ss for risperidone and total active moiety after oral and SC administration
| ng/mL | Oral Risperidone Followed by PERSERIS |
|---|---|
| Risperidone after oral dosing | 5.150 ± 43.3 |
| Risperidone after Dose 3 | 10.200 ± 65.3 |
| Total active moiety after oral dosing | 43.730 ± 34.8 |
| Total active moiety after Dose 3 | 44.049 ± 24.4 |
Injection site tolerability was measured by injection site grading for redness, induration, swelling and tenderness/pain. These were graded on a scale from 0 to 4 for severity (none, mild, moderate, severe and potentially life-threatening)
| Participants | Oral Risperidone Followed by PERSERIS |
|---|---|
| Dose 1 injection site pain grade — None | 22 |
| Dose 1 injection site pain grade — Mild | 1 |
| Dose 2 injection site pain grade — None | 19 |
| Dose 2 injection site pain grade — Mild | 1 |
| Dose 3 injection site pain grade — None | 16 |
| Dose 3 injection site pain grade — Mild | 0 |
| Dose 4 injection site pain grade — None | 15 |
| Dose 4 injection site pain grade — Mild | 1 |
| Dose 1 injection site tenderness grade — None | 21 |
| Dose 1 injection site tenderness grade — Mild | 2 |
| Dose 2 injection site tenderness grade — None | 18 |
| Dose 2 injection site tenderness grade — Mild | 2 |
| Dose 3 injection site tenderness grade — None | 15 |
| Dose 3 injection site tenderness grade — Mild | 1 |
| Dose 4 injection site tenderness grade — None | 13 |
| Dose 4 injection site tenderness grade — Mild | 3 |
| Dose 1 injection site erythema/redness grade — None | 22 |
| Dose 1 injection site erythema/redness grade — Mild | 1 |
| Dose 2 injection site erythema/redness grade — None | 20 |
| Dose 2 injection site erythema/redness grade — Mild | 0 |
| Dose 3 injection site erythema/redness grade — None | 16 |
| Dose 3 injection site erythema/redness grade — Mild | 0 |
| Dose 4 injection site erythema/redness grade — None | 16 |
| Dose 4 injection site erythema/redness grade — Mild | 0 |
| Dose 1 injection site induration/swelling grade — None | 23 |
| Dose 1 injection site induration/swelling grade — Mild | 0 |
| Dose 2 injection site induration/swelling grade — None | 20 |
| Dose 2 injection site induration/swelling grade — Mild | 0 |
| Dose 3 injection site induration/swelling grade — None | 15 |
| Dose 3 injection site induration/swelling grade — Mild | 1 |
| Dose 4 injection site induration/swelling grade — None | 14 |
| Dose 4 injection site induration/swelling grade — Mild | 2 |
The injection site was evaluated for adverse events by observation and examination by appropriately trained personnel.
| Participants | Oral Risperidone Followed by PERSERIS |
|---|---|
| The Number of Participants With TEAEs as Assessed by Local Injection Site* | 1 |
Vital sign measurement was performed, including orthostatic blood pressure, and clinically significant changes were reported as adverse events (AE). Vital sign measurement also included measurement of pulse rate, oral temperature and respiratory rate. Determination of whether the changes were AEs was made by the investigator or a medically qualified designee. If determined to be an AE, the measurement was repeated at appropriate intervals until the value returned to an acceptable range and the subject was clinically stable, a specific diagnosis was established, or the condition otherwise explained.
| Participants | Oral Risperidone Followed by PERSERIS |
|---|---|
| The Number of Participants With TEAEs as Assessed by Changes in Vital Signs | 1 |
ECGs were performed, and clinically significant changes in parameters were reported as adverse events (AE). ECGs were performed after 5 minutes of rest, and ECG parameters including QT interval, PR interval, QRS interval and heart rate was recorded. The ECG measurements were evaluated during the visit and determination of whether any abnormalities were AEs was made by the investigator or a medically qualified designee. If determined to be an AE, the measurement was repeated at appropriate intervals until the value returned to an acceptable range and the subject was clinically stable, a specific diagnosis was established, or the condition otherwise explained.
| Participants | Oral Risperidone Followed by PERSERIS |
|---|---|
| The Number of Participants With TEAEs as Assessed by Changes in ECG | 0 |
Body weight, with shoes off, was measured and clinically significant changes in weight was reported as adverse events (AE). Determination of whether the changes were AEs was made by the investigator or a medically qualified designee. If determined to be an AE, the measurement was repeated at appropriate intervals until the value returned to an acceptable range and the subject was clinically stable, a specific diagnosis was established, or the condition otherwise explained.
| Participants | Oral Risperidone Followed by PERSERIS |
|---|---|
| The Number of Participants With TEAEs as Assessed by Changes in Body Weight | 1 |
Laboratory testing was performed by the local clinical laboratory accredited by the College of American Pathologists, and clinically significant changes from baseline were reported as AEs. Subjects were expected to fast for a minimum of 8 hours prior to blood draws for all laboratory assessments except at the screening visit. Prior to entering the study, any abnormal laboratory test results were to be considered not clinically significant. Any abnormal hematology, serum chemistry or urinalysis test result after study drug intake that was determined by the investigator or a medically qualified designee to be clinically significant was reported as an AE. If determined to be an AE, the measurement was repeated at appropriate intervals until the value returned to an acceptable range or it was determined that resolution was not expected.
| Participants | Oral Risperidone Followed by PERSERIS |
|---|---|
| The Number of Participants With TEAEs as Assessed by Changes in Laboratory Testing | 3 |
Safety of treatment was measured by administration of symptom questionnaires including AIMS, Barnes Akathisia Rating Scale (BARS) and Simpson-Angus Scale (SAS), as well as by assessment by the investigator or suitably qualified medical designee. The AIMS is a tool that aids in early detection and ongoing monitoring of tardive dyskinesia, a movement disorder. The BARS is a 4-item scale that detects the presence and severity of any drug-induced restlessness. The SAS is a 10-item scale used to detect the presence of drug-induced Parkinsonism (movement disorder seen in Parkinson's disease) and extrapyramidal side effects and evaluates symptom severity. Extrapyramidal symptoms include involuntary or uncontrollable movements, tremors, and muscle contractions.
| Participants | Oral Risperidone Followed by PERSERIS |
|---|---|
| Akathisia | 1 |
| Dyskinesia | 2 |
| Parkinsonian gait | 1 |
| Tremor | 1 |
Clinical outcome (efficacy endpoint) as measured by change from baseline in PANSS scores was measured. PANSS is a medical scale designed to measure schizophrenia symptom severity utilizing a 30 item, 7-point rating scheme. The PANSS Is scored by a summation of ratings across items, with a total potential range of 7-210; higher results indicate greater severity of illness. Only total score changes from baseline are reported here.
| score on a scale | Oral Risperidone Followed by PERSERIS |
|---|---|
| Total score change from baseline: Dose 1 Day 2 | -0.2 ± 3.52 |
| Total score change from baseline: Dose 1 Day 8 | 0.9 ± 3.91 |
| Total score change from baseline: Dose 1 Day 15 | 0.7 ± 4.81 |
| Total score change from baseline: Dose 1 Day 22 | -0.4 ± 4.16 |
| Total score change from baseline: Dose 2 Day 29 | -0.9 ± 5.05 |
| Total score change from baseline: Dose 2 Day 50 | -0.5 ± 7.21 |
| Total score change from baseline: Dose 3 Day 57 | -2.9 ± 4.92 |
| Total score change from baseline: Dose 4 Day 85 | -0.9 ± 6.00 |
| Total score change from baseline: Day 113-EOS | 1.6 ± 6.22 |
Clinical outcome (efficacy endpoint) as measured by change from baseline in CGI-S scores was measured. The CGI-S is a measurement of the total severity of illness where one question is assessed. Responses range from 0 (not assessed) to 7 (most extremely ill).
| score on a scale | Oral Risperidone Followed by PERSERIS |
|---|---|
| Change from baseline: Dose 1/Day 2 | -0.1 ± 0.29 |
| Change from baseline: Dose 1/Day 8 | 0.0 ± 0.21 |
| Change from baseline: Dose 1/Day 15 | 0.0 ± 0.38 |
| Change from baseline: Dose 1/Day 22 | 0.0 ± 0.44 |
| Change from baseline: Dose 2/Day 29 | 0.0 ± 0.44 |
| Change from baseline: Dose 2/Day 50 | 0.0 ± 0.47 |
| Change from baseline: Dose 3/Day 57 | 0.1 ± 0.44 |
| Change from baseline: Dose 4/Day 85 | 0.1 ± 0.50 |
| Change from baseline: EOS/Day 113 | 0.0 ± 0.55 |
Significant changes from baseline in C-SSRS scores were reported as adverse events. The C-SSRS is based on a categorization of thoughts and behavior that are identified as related to suicidal behavior. The scale captures the occurrence, severity and frequency of suicide related thoughts and behaviors throughout lifetime at screening and for the time interval since last administration during a study. Responses are indicated as yes (thought or behavior did occur) or no (thought or behavior did not occur). If a yes response is received, then follow up questions are asked. The outcome of the C-SSRS is a numerical score obtained from each of the categories. Scores can range from 0-25, indicating the intensity rating, and any score greater than 0 may indicate the need for mental health intervention. Higher scores indicate greater intensity (i.e. worse outcome).
| score on a scale | Oral Risperidone Followed by PERSERIS |
|---|---|
| Change in Maximum Suicidal Ideation at Dose 1/Day 8 | 0.0 ± 0.00 |
| Change in Maximum Suicidal Ideation at EOS | 0.0 ± 0.00 |
| Change in Suicidal Ideation Intensity Score at Dose 1/Day 8 | 0.0 ± 0.00 |
| Change in Suicidal Ideation Intensity Score at EOS | 0.0 ± 0.00 |
| Change in Maximum Suicidal Behavior at Dose 1/Day 8 | 0.0 ± 0.00 |
| Change in Maximum Suicidal Behavior at EOS | 0.0 ± 0.00 |
Safety of treatment was measured by characterization of thoughts and behavior related to suicidal behavior. This was assessed by administration of the C-SSRS at designated visits. The scale captures the occurrence, severity and frequency of suicide related thoughts and behaviours throughout lifetime at screening and for the time interval since last administration during a study. Questions solicit the type of information needed to determine if a suicide-related thought or behavior occurred.
| Participants | Oral Risperidone Followed by PERSERIS |
|---|---|
| Any Suicidal Ideation - Lifetime — No | 15 |
| Any Suicidal Ideation - Lifetime — Yes | 8 |
| Any Suicidal Ideation - Past 6 months — No | 23 |
| Any Suicidal Ideation - Past 6 months — Yes | 0 |
| Any Suicidal Ideation - EOS — No | 14 |
| Any Suicidal Ideation - EOS — Yes | 0 |
| Any Suicidal Behavior - Lifetime — No | 17 |
| Any Suicidal Behavior - Lifetime — Yes | 6 |
| Any Suicidal Behavior - Past 6 months — No | 20 |
| Any Suicidal Behavior - Past 6 months — Yes | 0 |
| Any Suicidal Behavior - EOS — No | 14 |
| Any Suicidal Behavior - EOS — Yes | 0 |
| Any Suicidal Ideation or Behavior - Lifetime — No | 15 |
| Any Suicidal Ideation or Behavior - Lifetime — Yes | 8 |
| Any Suicidal Ideation or Behavior - Past 6 months — No | 20 |
| Any Suicidal Ideation or Behavior - Past 6 months — Yes | 0 |
| Any Suicidal Ideation or Behavior - EOS — No | 14 |
| Any Suicidal Ideation or Behavior - EOS — Yes | 0 |
Minimum observed plasma concentration of risperidone, 9-hydroxyrisperidone (9-OH) and total active moiety over the dosing interval after oral dosing and SC doses 1, 3 and 4
| ng/mL | Oral Risperidone Followed by PERSERIS |
|---|---|
| Risperidone after oral dosing | 1.066 ± 89.0 |
| Risperidone after Dose 1 | 3.017 ± 39.0 |
| Risperidone after Dose 3 | 4.519 ± 48.1 |
| Risperidone after Dose 4 | 5.020 ± 48.7 |
| 9-OH after oral dosing | 27.705 ± 41.7 |
| 9-OH after Dose 1 | 13.922 ± 63.6 |
| 9-OH after Dose 3 | 16.951 ± 41.6 |
| 9-OH after Dose 4 | 14.820 ± 46.3 |
| Total active moiety after oral dosing | 28.329 ± 39.6 |
| Total active moiety after Dose 1 | 17.852 ± 55.8 |
| Total active moiety after Dose 3 | 22.250 ± 37.7 |
| Total active moiety after Dose 4 | 22.063 ± 35.7 |
Maximum observed plasma concentration of risperidone, 9-hydroxyrisperidone (9-OH) and total active moiety over the dosing interval after oral dosing and SC doses 1, 3 and 4
| ng/mL | Oral Risperidone Followed by PERSERIS |
|---|---|
| Risperidone after oral dosing | 14.052 ± 45.2 |
| Risperidone after Dose 1 | 16.743 ± 57.1 |
| Risperidone after Dose 3 | 18.635 ± 54.6 |
| Risperidone after Dose 4 | 29.821 ± 65.1 |
| 9-OH after oral dosing | 45.464 ± 40.0 |
| 9-OH after Dose 1 | 45.285 ± 43.3 |
| 9-OH after Dose 3 | 56.476 ± 34.5 |
| 9-OH after Dose 4 | 52.240 ± 27.4 |
| Total active moiety after oral dosing | 58.453 ± 33.5 |
| Total active moiety after Dose 1 | 58.317 ± 38.4 |
| Total active moiety after Dose 3 | 70.597 ± 30.7 |
| Total active moiety after Dose 4 | 77.219 ± 32.5 |
Plasma concentration variation of risperidone, 9-OH and total active moiety over the dosing interval was measured by percent fluctuation after oral dosing and SC doses 1, 3 and 4 at steady state.
| percentage of fluctuation | Oral Risperidone Followed by PERSERIS |
|---|---|
| Risperidone after oral dosing | 253.335 ± 33.6 |
| Risperidone after Dose 1 | 174.653 ± 35.4 |
| Risperidone after Dose 3 | 135.267 ± 19.6 |
| Risperidone after Dose 4 | 190.117 ± 66.7 |
| 9-OH after oral dosing | 46.787 ± 32.0 |
| 9-OH after Dose 1 | 115.645 ± 48.1 |
| 9-OH after Dose 3 | 115.286 ± 55.5 |
| 9-OH after Dose 4 | 116.852 ± 44.7 |
| Total active moiety after oral dosing | 71.468 ± 26.0 |
| Total active moiety after Dose 1 | 115.113 ± 29.2 |
| Total active moiety after Dose 3 | 106.210 ± 28.6 |
| Total active moiety after Dose 4 | 118.435 ± 34.5 |
Area under the plasma concentration-time curve (AUC) was measured for risperidone, 9-OH and total active moiety.
| hr*ng/mL | Oral Risperidone Followed by PERSERIS |
|---|---|
| Risperidone after oral dosing | 60.354 ± 54.4 |
| Risperidone after Dose 1 | 5021.191 ± 55.0 |
| Risperidone after Dose 3 | 6854.855 ± 65.2 |
| Risperidone after Dose 4 | 7762.268 ± 63.6 |
| 9-OH after oral dosing | 432.801 ± 38.4 |
| 9-OH after Dose 1 | 17615.97 ± 44.0 |
| 9-OH after Dose 3 | 22203.31 ± 28.9 |
| 9-OH after Dose 4 | 20527.19 ± 30.2 |
| Total active moiety after oral dosing | 489.888 ± 34.0 |
| Total active moiety after Dose 1 | 22955.74 ± 37.5 |
| Total active moiety after Dose 3 | 29602.72 ± 24.4 |
| Total active moiety after Dose 4 | 29217.83 ± 23.4 |
Average plasma concentration of risperidone, 9-hydroxyrisperidone (9-OH) and total active moiety over the dosing interval after oral dosing and SC doses 1, 3 and 4.
| ng/mL | Oral Risperidone Followed by PERSERIS |
|---|---|
| Risperidone after oral dosing | 5.030 ± 54.4 |
| Risperidone after Dose 1 | 7.454 ± 55.2 |
| Risperidone after Dose 3 | 10.200 ± 65.3 |
| Risperidone after Dose 4 | 11.618 ± 63.2 |
| 9-OH after oral dosing | 36.066 ± 38.4 |
| 9-OH after Dose 1 | 26.148 ± 44.0 |
| 9-OH after Dose 3 | 33.039 ± 28.8 |
| 9-OH after Dose 4 | 30.723 ± 31.3 |
| Total active moiety after oral dosing | 40.823 ± 34.0 |
| Total active moiety after Dose 1 | 34.077 ± 37.5 |
| Total active moiety after Dose 3 | 44.049 ± 24.4 |
| Total active moiety after Dose 4 | 43.729 ± 24.0 |
Trough (pre-dose) plasma concentrations were measured for risperidone, 9-OH and total active moiety for SC doses 1, 3 and 4
| ng/mL | Oral Risperidone Followed by PERSERIS |
|---|---|
| Risperidone after Dose 1 | 1.766 ± 117.9 |
| Risperidone after dose 3 | 5.066 ± 48.0 |
| Risperidone after Dose 4 | 4.966 ± 62.9 |
| 9-OH after dose 1 | 33.696 ± 37.9 |
| 9-OH after dose 3 | 20.326 ± 51.0 |
| 9-OH after dose 4 | 17.983 ± 39.2 |
| Total active moiety after dose 1 | 35.553 ± 35.6 |
| Total active moiety after dose 3 | 25.468 ± 43.0 |
| Total active moiety after dose 4 | 23.125 ± 37.3 |
Time to maximal observed plasma concentration (Tmax) for risperidone, 9-OH, and total active moiety after oral dosing and SC doses 1, 3 and 4.
| hr | Oral Risperidone Followed by PERSERIS |
|---|---|
| Risperidone after oral dosing | 1.0 (0.50 to 4.00) |
| Risperidone after Dose 1 | 240.175 (4.03 to 576.23) |
| Risperidone after Dose 3 | 143.865 (2.03 to 503.32) |
| Risperidone after Dose 4 | 12.050 (2.03 to 383.87) |
| 9-OH after oral dosing | 1.990 (0.50 to 5.83) |
| 9-OH after Dose 1 | 204.515 (2.03 to 406.48) |
| 9-OH after Dose 3 | 182.535 (23.03 to 336.32) |
| 9-OH after Dose 4 | 118.120 (22.03 to 406.90) |
| Total active moiety after oral dosing | 1.010 (0.50 to 4.00) |
| Total active moiety after Dose 1 | 239.665 (4.03 to 407.87) |
| Total active moiety after Dose 3 | 182.535 (23.03 to 407.03) |
| Total active moiety after Dose 4 | 192.100 (6.03 to 406.90) |
Collected over Adverse event data was collected from the time of informed consent through the end of study for each subject, Day 120, a total of up to 146 days including the screening and dosing stabilization periods.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Risperidone Followed by PERSERIS | 0/23 (0%) | 1/23 (4.3%) | 9/23 (39.1%) |
| Event | Oral Risperidone Followed by PERSERIS |
|---|---|
| increase in liver enzymesHepatobiliary disorders | 1/23 |
| Event | Oral Risperidone Followed by PERSERIS |
|---|---|
| upper respiratory tract infectionInfections and infestations | 3/23 |
| blood prolactin increasedInvestigations | 2/23 |
| decreased appetiteMetabolism and nutrition disorders | 2/23 |
| dyskinesiaNervous system disorders | 2/23 |
| fallInjury, poisoning and procedural complications | 2/23 |
| headacheNervous system disorders | 2/23 |
The baseline number is the number of participants who received oral risperidone during the stabilization period and at least one PERSERIS injection. This equals the number of participants included in the safety and efficacy populations. There was one additional participant included in the PK population who had PK data from oral risperidone but did not receive PERSERIS and was not included in the safety population.
| Age, Continuous(years) | Oral Risperidone Followed by PERSERIS |
|---|---|
| Mean | 53.3 ± 10.98 |
| Sex: Female, Male(Participants) | Oral Risperidone Followed by PERSERIS |
|---|---|
| Female | 9 |
| Male | 14 |
| Ethnicity (NIH/OMB)(Participants) | Oral Risperidone Followed by PERSERIS |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Oral Risperidone Followed by PERSERIS |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 17 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Body Mass Index(kg/m^2) | Oral Risperidone Followed by PERSERIS |
|---|---|
| Mean | 28.49 ± 4.650 |
| CYP2D6 Genotype(Participants) | Oral Risperidone Followed by PERSERIS |
|---|---|
| Poor | 0 |
| Intermediate | 0 |
| Extensive | 23 |
| Ultra-rapid | 0 |
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Indivior Inc.