Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone (NCT NCT03978832)
NCT ID: NCT03978832
Last Updated: 2021-07-07
Results Overview
Cavg,ss for risperidone and total active moiety after oral and SC administration
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
69 participants
Primary outcome timeframe
0-12 hours post-dose on Day -1, and 0-672 hours after Dose 3
Results posted on
2021-07-07
Participant Flow
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.
After providing informed consent potential participants were screened, and after eligibility was confirmed, participants were stabilized on 6 mg daily of oral risperidone (3 mg administered twice a day \[BID\] approximately 12 hours apart) for 5 days. After completion of the stabilization period, participants were eligible to receive 180 mg PERSERIS (subcutaneous risperidone), administered as two 90 mg SC injections every 28 days.
Participant milestones
| Measure |
Oral Risperidone Followed by PERSERIS
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Overall Study
STARTED
|
69
|
|
Overall Study
Stabilization Period
|
25
|
|
Overall Study
Treatment Period
|
23
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
Oral Risperidone Followed by PERSERIS
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
did not pass screening criteria
|
44
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone
Baseline characteristics by cohort
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Body Mass Index
|
28.49 kg/m^2
STANDARD_DEVIATION 4.650 • n=5 Participants
|
|
CYP2D6 Genotype
Poor
|
0 Participants
n=5 Participants
|
|
CYP2D6 Genotype
Intermediate
|
0 Participants
n=5 Participants
|
|
CYP2D6 Genotype
Extensive
|
23 Participants
n=5 Participants
|
|
CYP2D6 Genotype
Ultra-rapid
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-12 hours post-dose on Day -1, and 0-672 hours after Dose 3Population: The primary PK analysis was conducted in participants who received at least 3 doses of PERSERIS 180 mg and provided adequate blood samples for the determination of Cavg after the third dose (primary PK population).
Cavg,ss for risperidone and total active moiety after oral and SC administration
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=16 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Steady-state Average Plasma Concentration (Cavg,ss) of Risperidone and Total Active Moiety
Risperidone after oral dosing
|
5.150 ng/mL
Geometric Coefficient of Variation 43.3
|
|
Steady-state Average Plasma Concentration (Cavg,ss) of Risperidone and Total Active Moiety
Risperidone after Dose 3
|
10.200 ng/mL
Geometric Coefficient of Variation 65.3
|
|
Steady-state Average Plasma Concentration (Cavg,ss) of Risperidone and Total Active Moiety
Total active moiety after oral dosing
|
43.730 ng/mL
Geometric Coefficient of Variation 34.8
|
|
Steady-state Average Plasma Concentration (Cavg,ss) of Risperidone and Total Active Moiety
Total active moiety after Dose 3
|
44.049 ng/mL
Geometric Coefficient of Variation 24.4
|
SECONDARY outcome
Timeframe: First injection at Day 1 until last injection administered at Day 85Population: The number of participants assessed is the actual number who received the injection at each visit. \*By the nature of this outcome measure (injection site), all results are reported for participants who had received PERSERIS
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)
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Assessment of Local Injection Site Tolerability*
Dose 1 injection site pain grade · None
|
22 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 1 injection site pain grade · Mild
|
1 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 2 injection site pain grade · None
|
19 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 2 injection site pain grade · Mild
|
1 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 3 injection site pain grade · None
|
16 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 3 injection site pain grade · Mild
|
0 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 4 injection site pain grade · None
|
15 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 4 injection site pain grade · Mild
|
1 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 1 injection site tenderness grade · None
|
21 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 1 injection site tenderness grade · Mild
|
2 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 2 injection site tenderness grade · None
|
18 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 2 injection site tenderness grade · Mild
|
2 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 3 injection site tenderness grade · None
|
15 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 3 injection site tenderness grade · Mild
|
1 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 4 injection site tenderness grade · None
|
13 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 4 injection site tenderness grade · Mild
|
3 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 1 injection site erythema/redness grade · None
|
22 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 1 injection site erythema/redness grade · Mild
|
1 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 2 injection site erythema/redness grade · None
|
20 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 2 injection site erythema/redness grade · Mild
|
0 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 3 injection site erythema/redness grade · None
|
16 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 3 injection site erythema/redness grade · Mild
|
0 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 4 injection site erythema/redness grade · None
|
16 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 4 injection site erythema/redness grade · Mild
|
0 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 1 injection site induration/swelling grade · None
|
23 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 1 injection site induration/swelling grade · Mild
|
0 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 2 injection site induration/swelling grade · None
|
20 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 2 injection site induration/swelling grade · Mild
|
0 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 3 injection site induration/swelling grade · None
|
15 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 3 injection site induration/swelling grade · Mild
|
1 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 4 injection site induration/swelling grade · None
|
14 Participants
|
|
Assessment of Local Injection Site Tolerability*
Dose 4 injection site induration/swelling grade · Mild
|
2 Participants
|
SECONDARY outcome
Timeframe: First injection at Day 1 until Day 120Population: \*By the nature of this outcome measure (injection site), all results are reported for participants who had received PERSERIS
The injection site was evaluated for adverse events by observation and examination by appropriately trained personnel.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
The Number of Participants With TEAEs as Assessed by Local Injection Site*
|
1 Participants
|
SECONDARY outcome
Timeframe: Time subjects sign the informed consent form throughout the study until EOS (Day 113)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.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
The Number of Participants With TEAEs as Assessed by Changes in Vital Signs
|
1 Participants
|
SECONDARY outcome
Timeframe: Time participants sign the informed consent form throughout the study until EOS (Day 113)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.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
The Number of Participants With TEAEs as Assessed by Changes in ECG
|
0 Participants
|
SECONDARY outcome
Timeframe: Time subjects sign the informed consent form throughout the study until EOS (Day 113)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.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
The Number of Participants With TEAEs as Assessed by Changes in Body Weight
|
1 Participants
|
SECONDARY outcome
Timeframe: Time subjects sign the informed consent form throughout the study until end of study (EOS) visit (Day 113)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.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
The Number of Participants With TEAEs as Assessed by Changes in Laboratory Testing
|
3 Participants
|
SECONDARY outcome
Timeframe: Time subjects sign the informed consent form throughout the study until EOS (Day 113)Population: There were no clinically important differences in mean scores across study visits. TEAEs related to EPS are reported below
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.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
The Number of Participants With TEAEs as Assessed by Extrapyramidal Symptoms (EPS) of Anti-psychotic Drug Treatment
Akathisia
|
1 Participants
|
|
The Number of Participants With TEAEs as Assessed by Extrapyramidal Symptoms (EPS) of Anti-psychotic Drug Treatment
Dyskinesia
|
2 Participants
|
|
The Number of Participants With TEAEs as Assessed by Extrapyramidal Symptoms (EPS) of Anti-psychotic Drug Treatment
Parkinsonian gait
|
1 Participants
|
|
The Number of Participants With TEAEs as Assessed by Extrapyramidal Symptoms (EPS) of Anti-psychotic Drug Treatment
Tremor
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, defined as last assessment prior to first injection, through Day 113 (EOS)Population: PANSS total scores change from baseline measure from baseline through Day 113 for those participants with results reported
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.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Total score change from baseline: Dose 4 Day 85
|
-0.9 score on a scale
Standard Deviation 6.00
|
|
Positive and Negative Syndrome Scale (PANSS)
Total score change from baseline: Day 113-EOS
|
1.6 score on a scale
Standard Deviation 6.22
|
|
Positive and Negative Syndrome Scale (PANSS)
Total score change from baseline: Dose 1 Day 2
|
-0.2 score on a scale
Standard Deviation 3.52
|
|
Positive and Negative Syndrome Scale (PANSS)
Total score change from baseline: Dose 1 Day 8
|
0.9 score on a scale
Standard Deviation 3.91
|
|
Positive and Negative Syndrome Scale (PANSS)
Total score change from baseline: Dose 1 Day 15
|
0.7 score on a scale
Standard Deviation 4.81
|
|
Positive and Negative Syndrome Scale (PANSS)
Total score change from baseline: Dose 1 Day 22
|
-0.4 score on a scale
Standard Deviation 4.16
|
|
Positive and Negative Syndrome Scale (PANSS)
Total score change from baseline: Dose 2 Day 29
|
-0.9 score on a scale
Standard Deviation 5.05
|
|
Positive and Negative Syndrome Scale (PANSS)
Total score change from baseline: Dose 2 Day 50
|
-0.5 score on a scale
Standard Deviation 7.21
|
|
Positive and Negative Syndrome Scale (PANSS)
Total score change from baseline: Dose 3 Day 57
|
-2.9 score on a scale
Standard Deviation 4.92
|
SECONDARY outcome
Timeframe: Baseline through EOS (Day 113)Population: Severity of illness observed values were measured and change from baseline calculated for those participants with results reported.
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).
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Clinical Global Impression-Severity of Illness Scale (CGI-S)
Change from baseline: Dose 4/Day 85
|
0.1 score on a scale
Standard Deviation 0.50
|
|
Clinical Global Impression-Severity of Illness Scale (CGI-S)
Change from baseline: EOS/Day 113
|
0.0 score on a scale
Standard Deviation 0.55
|
|
Clinical Global Impression-Severity of Illness Scale (CGI-S)
Change from baseline: Dose 1/Day 2
|
-0.1 score on a scale
Standard Deviation 0.29
|
|
Clinical Global Impression-Severity of Illness Scale (CGI-S)
Change from baseline: Dose 1/Day 8
|
0.0 score on a scale
Standard Deviation 0.21
|
|
Clinical Global Impression-Severity of Illness Scale (CGI-S)
Change from baseline: Dose 1/Day 15
|
0.0 score on a scale
Standard Deviation 0.38
|
|
Clinical Global Impression-Severity of Illness Scale (CGI-S)
Change from baseline: Dose 1/Day 22
|
0.0 score on a scale
Standard Deviation 0.44
|
|
Clinical Global Impression-Severity of Illness Scale (CGI-S)
Change from baseline: Dose 2/Day 29
|
0.0 score on a scale
Standard Deviation 0.44
|
|
Clinical Global Impression-Severity of Illness Scale (CGI-S)
Change from baseline: Dose 2/Day 50
|
0.0 score on a scale
Standard Deviation 0.47
|
|
Clinical Global Impression-Severity of Illness Scale (CGI-S)
Change from baseline: Dose 3/Day 57
|
0.1 score on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Screening through EOS (Day 113)Population: Only actual number of participants assessed at visit was reported. Only change in suicidal behavior from baseline at Dose 1/Day 8 (first measure after baseline) and EOS is reported as all numbers are zero.
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).
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)-Change
Change in Maximum Suicidal Ideation at Dose 1/Day 8
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)-Change
Change in Maximum Suicidal Ideation at EOS
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)-Change
Change in Suicidal Ideation Intensity Score at Dose 1/Day 8
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)-Change
Change in Suicidal Ideation Intensity Score at EOS
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)-Change
Change in Maximum Suicidal Behavior at Dose 1/Day 8
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)-Change
Change in Maximum Suicidal Behavior at EOS
|
0.0 score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Screening through EOS (Day 113)Population: Only actual number of participants assessed at visit was reported. Only results for lifetime, past 6 months and EOS are reported as all responses are 'no' after lifetime.
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.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation - Lifetime · No
|
15 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation - Lifetime · Yes
|
8 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation - Past 6 months · No
|
23 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation - Past 6 months · Yes
|
0 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation - EOS · No
|
14 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation - EOS · Yes
|
0 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Behavior - Lifetime · No
|
17 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Behavior - Lifetime · Yes
|
6 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Behavior - Past 6 months · No
|
20 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Behavior - Past 6 months · Yes
|
0 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Behavior - EOS · No
|
14 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Behavior - EOS · Yes
|
0 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation or Behavior - Lifetime · No
|
15 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation or Behavior - Lifetime · Yes
|
8 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation or Behavior - Past 6 months · No
|
20 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation or Behavior - Past 6 months · Yes
|
0 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation or Behavior - EOS · No
|
14 Participants
|
|
Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Any Suicidal Ideation or Behavior - EOS · Yes
|
0 Participants
|
SECONDARY outcome
Timeframe: Calculated over the dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4).Population: PK population. Actual number of participants analyzed for each period is reported
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
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=24 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Minimum Plasma Concentration Over the Dosing Interval
Risperidone after oral dosing
|
1.066 ng/mL
Geometric Coefficient of Variation 89.0
|
|
Minimum Plasma Concentration Over the Dosing Interval
Risperidone after Dose 1
|
3.017 ng/mL
Geometric Coefficient of Variation 39.0
|
|
Minimum Plasma Concentration Over the Dosing Interval
Risperidone after Dose 3
|
4.519 ng/mL
Geometric Coefficient of Variation 48.1
|
|
Minimum Plasma Concentration Over the Dosing Interval
Risperidone after Dose 4
|
5.020 ng/mL
Geometric Coefficient of Variation 48.7
|
|
Minimum Plasma Concentration Over the Dosing Interval
9-OH after oral dosing
|
27.705 ng/mL
Geometric Coefficient of Variation 41.7
|
|
Minimum Plasma Concentration Over the Dosing Interval
9-OH after Dose 1
|
13.922 ng/mL
Geometric Coefficient of Variation 63.6
|
|
Minimum Plasma Concentration Over the Dosing Interval
9-OH after Dose 3
|
16.951 ng/mL
Geometric Coefficient of Variation 41.6
|
|
Minimum Plasma Concentration Over the Dosing Interval
9-OH after Dose 4
|
14.820 ng/mL
Geometric Coefficient of Variation 46.3
|
|
Minimum Plasma Concentration Over the Dosing Interval
Total active moiety after oral dosing
|
28.329 ng/mL
Geometric Coefficient of Variation 39.6
|
|
Minimum Plasma Concentration Over the Dosing Interval
Total active moiety after Dose 1
|
17.852 ng/mL
Geometric Coefficient of Variation 55.8
|
|
Minimum Plasma Concentration Over the Dosing Interval
Total active moiety after Dose 3
|
22.250 ng/mL
Geometric Coefficient of Variation 37.7
|
|
Minimum Plasma Concentration Over the Dosing Interval
Total active moiety after Dose 4
|
22.063 ng/mL
Geometric Coefficient of Variation 35.7
|
SECONDARY outcome
Timeframe: Calculated over the dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4)Population: Analysis population is the PK population. Actual number of participants analyzed for each period is reported.
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
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=24 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Maximum Plasma Concentration Over the Dosing Interval
Risperidone after oral dosing
|
14.052 ng/mL
Geometric Coefficient of Variation 45.2
|
|
Maximum Plasma Concentration Over the Dosing Interval
Risperidone after Dose 1
|
16.743 ng/mL
Geometric Coefficient of Variation 57.1
|
|
Maximum Plasma Concentration Over the Dosing Interval
Risperidone after Dose 3
|
18.635 ng/mL
Geometric Coefficient of Variation 54.6
|
|
Maximum Plasma Concentration Over the Dosing Interval
Risperidone after Dose 4
|
29.821 ng/mL
Geometric Coefficient of Variation 65.1
|
|
Maximum Plasma Concentration Over the Dosing Interval
9-OH after oral dosing
|
45.464 ng/mL
Geometric Coefficient of Variation 40.0
|
|
Maximum Plasma Concentration Over the Dosing Interval
9-OH after Dose 1
|
45.285 ng/mL
Geometric Coefficient of Variation 43.3
|
|
Maximum Plasma Concentration Over the Dosing Interval
9-OH after Dose 3
|
56.476 ng/mL
Geometric Coefficient of Variation 34.5
|
|
Maximum Plasma Concentration Over the Dosing Interval
9-OH after Dose 4
|
52.240 ng/mL
Geometric Coefficient of Variation 27.4
|
|
Maximum Plasma Concentration Over the Dosing Interval
Total active moiety after oral dosing
|
58.453 ng/mL
Geometric Coefficient of Variation 33.5
|
|
Maximum Plasma Concentration Over the Dosing Interval
Total active moiety after Dose 1
|
58.317 ng/mL
Geometric Coefficient of Variation 38.4
|
|
Maximum Plasma Concentration Over the Dosing Interval
Total active moiety after Dose 3
|
70.597 ng/mL
Geometric Coefficient of Variation 30.7
|
|
Maximum Plasma Concentration Over the Dosing Interval
Total active moiety after Dose 4
|
77.219 ng/mL
Geometric Coefficient of Variation 32.5
|
SECONDARY outcome
Timeframe: Calculated over the dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4)Population: PK population. Actual number of participants analyzed for each period is reported
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.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=24 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Percent Fluctuation in Concentration Over the Dosing Interval
9-OH after Dose 1
|
115.645 percentage of fluctuation
Geometric Coefficient of Variation 48.1
|
|
Percent Fluctuation in Concentration Over the Dosing Interval
9-OH after Dose 3
|
115.286 percentage of fluctuation
Geometric Coefficient of Variation 55.5
|
|
Percent Fluctuation in Concentration Over the Dosing Interval
9-OH after Dose 4
|
116.852 percentage of fluctuation
Geometric Coefficient of Variation 44.7
|
|
Percent Fluctuation in Concentration Over the Dosing Interval
Risperidone after oral dosing
|
253.335 percentage of fluctuation
Geometric Coefficient of Variation 33.6
|
|
Percent Fluctuation in Concentration Over the Dosing Interval
Risperidone after Dose 1
|
174.653 percentage of fluctuation
Geometric Coefficient of Variation 35.4
|
|
Percent Fluctuation in Concentration Over the Dosing Interval
Risperidone after Dose 3
|
135.267 percentage of fluctuation
Geometric Coefficient of Variation 19.6
|
|
Percent Fluctuation in Concentration Over the Dosing Interval
Risperidone after Dose 4
|
190.117 percentage of fluctuation
Geometric Coefficient of Variation 66.7
|
|
Percent Fluctuation in Concentration Over the Dosing Interval
9-OH after oral dosing
|
46.787 percentage of fluctuation
Geometric Coefficient of Variation 32.0
|
|
Percent Fluctuation in Concentration Over the Dosing Interval
Total active moiety after oral dosing
|
71.468 percentage of fluctuation
Geometric Coefficient of Variation 26.0
|
|
Percent Fluctuation in Concentration Over the Dosing Interval
Total active moiety after Dose 1
|
115.113 percentage of fluctuation
Geometric Coefficient of Variation 29.2
|
|
Percent Fluctuation in Concentration Over the Dosing Interval
Total active moiety after Dose 3
|
106.210 percentage of fluctuation
Geometric Coefficient of Variation 28.6
|
|
Percent Fluctuation in Concentration Over the Dosing Interval
Total active moiety after Dose 4
|
118.435 percentage of fluctuation
Geometric Coefficient of Variation 34.5
|
SECONDARY outcome
Timeframe: Calculated over the dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4).Population: PK population; actual number of participants analyzed for each period is reported
Area under the plasma concentration-time curve (AUC) was measured for risperidone, 9-OH and total active moiety.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=24 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
9-OH after oral dosing
|
432.801 hr*ng/mL
Geometric Coefficient of Variation 38.4
|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
9-OH after Dose 1
|
17615.97 hr*ng/mL
Geometric Coefficient of Variation 44.0
|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
Risperidone after oral dosing
|
60.354 hr*ng/mL
Geometric Coefficient of Variation 54.4
|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
Risperidone after Dose 1
|
5021.191 hr*ng/mL
Geometric Coefficient of Variation 55.0
|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
Risperidone after Dose 3
|
6854.855 hr*ng/mL
Geometric Coefficient of Variation 65.2
|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
Risperidone after Dose 4
|
7762.268 hr*ng/mL
Geometric Coefficient of Variation 63.6
|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
9-OH after Dose 3
|
22203.31 hr*ng/mL
Geometric Coefficient of Variation 28.9
|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
9-OH after Dose 4
|
20527.19 hr*ng/mL
Geometric Coefficient of Variation 30.2
|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
Total active moiety after oral dosing
|
489.888 hr*ng/mL
Geometric Coefficient of Variation 34.0
|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
Total active moiety after Dose 1
|
22955.74 hr*ng/mL
Geometric Coefficient of Variation 37.5
|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
Total active moiety after Dose 3
|
29602.72 hr*ng/mL
Geometric Coefficient of Variation 24.4
|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval
Total active moiety after Dose 4
|
29217.83 hr*ng/mL
Geometric Coefficient of Variation 23.4
|
SECONDARY outcome
Timeframe: Calculated over the dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4).Population: PK population; actual number of participants analyzed for each period is reported
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.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=24 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
Risperidone after oral dosing
|
5.030 ng/mL
Geometric Coefficient of Variation 54.4
|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
Risperidone after Dose 1
|
7.454 ng/mL
Geometric Coefficient of Variation 55.2
|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
Risperidone after Dose 3
|
10.200 ng/mL
Geometric Coefficient of Variation 65.3
|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
Risperidone after Dose 4
|
11.618 ng/mL
Geometric Coefficient of Variation 63.2
|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
9-OH after oral dosing
|
36.066 ng/mL
Geometric Coefficient of Variation 38.4
|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
9-OH after Dose 1
|
26.148 ng/mL
Geometric Coefficient of Variation 44.0
|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
9-OH after Dose 3
|
33.039 ng/mL
Geometric Coefficient of Variation 28.8
|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
9-OH after Dose 4
|
30.723 ng/mL
Geometric Coefficient of Variation 31.3
|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
Total active moiety after oral dosing
|
40.823 ng/mL
Geometric Coefficient of Variation 34.0
|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
Total active moiety after Dose 1
|
34.077 ng/mL
Geometric Coefficient of Variation 37.5
|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
Total active moiety after Dose 3
|
44.049 ng/mL
Geometric Coefficient of Variation 24.4
|
|
Average Plasma Concentration (Cavg) Over the Dosing Interval of Risperidone, 9-OH and Total Active Moiety
Total active moiety after Dose 4
|
43.729 ng/mL
Geometric Coefficient of Variation 24.0
|
SECONDARY outcome
Timeframe: Calculated over the dosing interval (0-672 hours) after Dose 1, 3 or 4.Population: PK population; actual number of participants analyzed for each period is reported.
Trough (pre-dose) plasma concentrations were measured for risperidone, 9-OH and total active moiety for SC doses 1, 3 and 4
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=24 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Trough Plasma Concentration
9-OH after dose 1
|
33.696 ng/mL
Geometric Coefficient of Variation 37.9
|
|
Trough Plasma Concentration
9-OH after dose 3
|
20.326 ng/mL
Geometric Coefficient of Variation 51.0
|
|
Trough Plasma Concentration
Risperidone after Dose 1
|
1.766 ng/mL
Geometric Coefficient of Variation 117.9
|
|
Trough Plasma Concentration
Risperidone after dose 3
|
5.066 ng/mL
Geometric Coefficient of Variation 48.0
|
|
Trough Plasma Concentration
Risperidone after Dose 4
|
4.966 ng/mL
Geometric Coefficient of Variation 62.9
|
|
Trough Plasma Concentration
9-OH after dose 4
|
17.983 ng/mL
Geometric Coefficient of Variation 39.2
|
|
Trough Plasma Concentration
Total active moiety after dose 1
|
35.553 ng/mL
Geometric Coefficient of Variation 35.6
|
|
Trough Plasma Concentration
Total active moiety after dose 3
|
25.468 ng/mL
Geometric Coefficient of Variation 43.0
|
|
Trough Plasma Concentration
Total active moiety after dose 4
|
23.125 ng/mL
Geometric Coefficient of Variation 37.3
|
SECONDARY outcome
Timeframe: Calculated over the overall dosing interval (0-12 hours on Day -1, or 0-672 hours after Dose 1, 3 or 4).Population: PK population; actual number of participants analyzed for each period is reported
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.
Outcome measures
| Measure |
Oral Risperidone Followed by PERSERIS
n=24 Participants
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS (subcutaneous risperidone) is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
|
|---|---|
|
Time to Occurrence of Maximum Concentration
Risperidone after oral dosing
|
1.0 hr
Interval 0.5 to 4.0
|
|
Time to Occurrence of Maximum Concentration
Risperidone after Dose 1
|
240.175 hr
Interval 4.03 to 576.23
|
|
Time to Occurrence of Maximum Concentration
Risperidone after Dose 3
|
143.865 hr
Interval 2.03 to 503.32
|
|
Time to Occurrence of Maximum Concentration
Risperidone after Dose 4
|
12.050 hr
Interval 2.03 to 383.87
|
|
Time to Occurrence of Maximum Concentration
9-OH after oral dosing
|
1.990 hr
Interval 0.5 to 5.83
|
|
Time to Occurrence of Maximum Concentration
9-OH after Dose 1
|
204.515 hr
Interval 2.03 to 406.48
|
|
Time to Occurrence of Maximum Concentration
9-OH after Dose 3
|
182.535 hr
Interval 23.03 to 336.32
|
|
Time to Occurrence of Maximum Concentration
9-OH after Dose 4
|
118.120 hr
Interval 22.03 to 406.9
|
|
Time to Occurrence of Maximum Concentration
Total active moiety after oral dosing
|
1.010 hr
Interval 0.5 to 4.0
|
|
Time to Occurrence of Maximum Concentration
Total active moiety after Dose 1
|
239.665 hr
Interval 4.03 to 407.87
|
|
Time to Occurrence of Maximum Concentration
Total active moiety after Dose 3
|
182.535 hr
Interval 23.03 to 407.03
|
|
Time to Occurrence of Maximum Concentration
Total active moiety after Dose 4
|
192.100 hr
Interval 6.03 to 406.9
|
Adverse Events
Oral Risperidone Followed by PERSERIS
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 participants at risk
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
Outcome measures and adverse events were not reported by intervention, but by number of participants who experienced the adverse event. Based on narrative, it was possible to determine the timing of the serious adverse event. By nature of the adverse event, any injection site reported adverse events or outcome data occurred in participants who had received PERSERIS
|
|---|---|
|
Hepatobiliary disorders
increase in liver enzymes
|
4.3%
1/23 • Number of events 1 • 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.
Adverse events (AE) were collected through a combination of systemic and non-systemic methods. AEs were collected through self-reporting by participants, and systemic methods included scheduled laboratory testing, investigator assessments of disease severity through PANSS, CGI-S and other scales, injection site assessments, ECGs, pregnancy testing for women of child-bearing potential. The one serious AE and all AEs above the frequency reporting threshold occurred in subjects receiving PERSERIS
|
Other adverse events
| Measure |
Oral Risperidone Followed by PERSERIS
n=23 participants at risk
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
Outcome measures and adverse events were not reported by intervention, but by number of participants who experienced the adverse event. Based on narrative, it was possible to determine the timing of the serious adverse event. By nature of the adverse event, any injection site reported adverse events or outcome data occurred in participants who had received PERSERIS
|
|---|---|
|
Infections and infestations
upper respiratory tract infection
|
13.0%
3/23 • Number of events 3 • 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.
Adverse events (AE) were collected through a combination of systemic and non-systemic methods. AEs were collected through self-reporting by participants, and systemic methods included scheduled laboratory testing, investigator assessments of disease severity through PANSS, CGI-S and other scales, injection site assessments, ECGs, pregnancy testing for women of child-bearing potential. The one serious AE and all AEs above the frequency reporting threshold occurred in subjects receiving PERSERIS
|
|
Investigations
blood prolactin increased
|
8.7%
2/23 • Number of events 2 • 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.
Adverse events (AE) were collected through a combination of systemic and non-systemic methods. AEs were collected through self-reporting by participants, and systemic methods included scheduled laboratory testing, investigator assessments of disease severity through PANSS, CGI-S and other scales, injection site assessments, ECGs, pregnancy testing for women of child-bearing potential. The one serious AE and all AEs above the frequency reporting threshold occurred in subjects receiving PERSERIS
|
|
Metabolism and nutrition disorders
decreased appetite
|
8.7%
2/23 • Number of events 2 • 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.
Adverse events (AE) were collected through a combination of systemic and non-systemic methods. AEs were collected through self-reporting by participants, and systemic methods included scheduled laboratory testing, investigator assessments of disease severity through PANSS, CGI-S and other scales, injection site assessments, ECGs, pregnancy testing for women of child-bearing potential. The one serious AE and all AEs above the frequency reporting threshold occurred in subjects receiving PERSERIS
|
|
Nervous system disorders
dyskinesia
|
8.7%
2/23 • Number of events 2 • 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.
Adverse events (AE) were collected through a combination of systemic and non-systemic methods. AEs were collected through self-reporting by participants, and systemic methods included scheduled laboratory testing, investigator assessments of disease severity through PANSS, CGI-S and other scales, injection site assessments, ECGs, pregnancy testing for women of child-bearing potential. The one serious AE and all AEs above the frequency reporting threshold occurred in subjects receiving PERSERIS
|
|
Injury, poisoning and procedural complications
fall
|
8.7%
2/23 • Number of events 2 • 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.
Adverse events (AE) were collected through a combination of systemic and non-systemic methods. AEs were collected through self-reporting by participants, and systemic methods included scheduled laboratory testing, investigator assessments of disease severity through PANSS, CGI-S and other scales, injection site assessments, ECGs, pregnancy testing for women of child-bearing potential. The one serious AE and all AEs above the frequency reporting threshold occurred in subjects receiving PERSERIS
|
|
Nervous system disorders
headache
|
8.7%
2/23 • Number of events 2 • 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.
Adverse events (AE) were collected through a combination of systemic and non-systemic methods. AEs were collected through self-reporting by participants, and systemic methods included scheduled laboratory testing, investigator assessments of disease severity through PANSS, CGI-S and other scales, injection site assessments, ECGs, pregnancy testing for women of child-bearing potential. The one serious AE and all AEs above the frequency reporting threshold occurred in subjects receiving PERSERIS
|
Additional Information
PERSERIS Medicines Development Lead and Head Global Clinical Operations and Development
Indivior Inc
Phone: 804 379-1090
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator and Institution may have access to the Case Report Forms resulting solely from their participation in the study for purely scientific or educational purposes, but unless previously explicitly permitted in writing by the Sponsor, Principal Investigator and Institution may not use it for any publication, presentation, disclosure, or commercial purposes.
- Publication restrictions are in place
Restriction type: OTHER