Trial Outcomes & Findings for A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging (NCT NCT04038957)
NCT ID: NCT04038957
Last Updated: 2024-12-27
Results Overview
Dopamine synthesis capacity was assessed using 18 F-DOPA PET(positron emission tomography) scans that were performed before (baseline) and after (Week 2 \[Day 14\]) administration of SEP-363856 adjunctive to an antipsychotic medication. A repeated measures ANOVA(analysis of variance) analysis was conducted. The dependent variable was Dopamine Synthesis Capacity (Ki Values). The independent variables were Time and Striatal Subregion. The covariance matrix was unstructured for each subject's Time and Striatal Subregion.
COMPLETED
PHASE1
22 participants
baseline and week 2
2024-12-27
Participant Flow
Participant milestones
| Measure |
SEP-363856
SEP-363856 50mg, 75mg flexible dosing, dosed once daily
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
SEP-363856
SEP-363856 50mg, 75mg flexible dosing, dosed once daily
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
SUBJECT WAS WITHDRAWN DUE TO SAFETY REASON
|
1
|
Baseline Characteristics
A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging
Baseline characteristics by cohort
| Measure |
SEP-363856
n=22 Participants
SEP-363856 50mg, 75mg flexible dosing, dosed once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.5 Years
STANDARD_DEVIATION 6.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 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
|
2 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
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and week 2Dopamine synthesis capacity was assessed using 18 F-DOPA PET(positron emission tomography) scans that were performed before (baseline) and after (Week 2 \[Day 14\]) administration of SEP-363856 adjunctive to an antipsychotic medication. A repeated measures ANOVA(analysis of variance) analysis was conducted. The dependent variable was Dopamine Synthesis Capacity (Ki Values). The independent variables were Time and Striatal Subregion. The covariance matrix was unstructured for each subject's Time and Striatal Subregion.
Outcome measures
| Measure |
SEP-363856
n=19 Participants
SEP-363856 50mg, 75mg flexible dosing, dosed once daily
|
|---|---|
|
Change From Baseline in Dopamine Synthesis Capacity at Week 2 Using 18F-DOPA.
Whole Striatal Dopamine Synthesis Capacity
|
-0.0007 Kicer
Standard Deviation 0.00157
|
|
Change From Baseline in Dopamine Synthesis Capacity at Week 2 Using 18F-DOPA.
Limbic Striatal Dopamine Synthesis Capacity
|
-0.0008 Kicer
Standard Deviation 0.00118
|
|
Change From Baseline in Dopamine Synthesis Capacity at Week 2 Using 18F-DOPA.
Associative Striatal Dopamine Synthesis Capacity
|
-0.0006 Kicer
Standard Deviation 0.00158
|
|
Change From Baseline in Dopamine Synthesis Capacity at Week 2 Using 18F-DOPA.
Sensorimotor Striatal Dopamine Synthesis Capacity
|
-0.0008 Kicer
Standard Deviation 0.00207
|
Adverse Events
SEP-363856
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SEP-363856
n=22 participants at risk
SEP-363856 50mg, 75mg flexible dosing, dosed once daily
|
|---|---|
|
Eye disorders
Vision blurred
|
9.1%
2/22 • Number of events 2 • Up to 36 days
|
|
Gastrointestinal disorders
Dry mouth
|
18.2%
4/22 • Number of events 4 • Up to 36 days
|
|
Gastrointestinal disorders
Nausea
|
13.6%
3/22 • Number of events 3 • Up to 36 days
|
|
General disorders
Fatigue
|
9.1%
2/22 • Number of events 2 • Up to 36 days
|
|
Nervous system disorders
Dizziness
|
36.4%
8/22 • Number of events 8 • Up to 36 days
|
|
Nervous system disorders
Headache
|
18.2%
4/22 • Number of events 4 • Up to 36 days
|
|
Nervous system disorders
Presyncope
|
9.1%
2/22 • Number of events 2 • Up to 36 days
|
|
Nervous system disorders
Somnolence
|
63.6%
14/22 • Number of events 15 • Up to 36 days
|
|
Psychiatric disorders
Insomnia
|
9.1%
2/22 • Number of events 2 • Up to 36 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish
- Publication restrictions are in place
Restriction type: OTHER