SEP-363856 for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
SchizophreniaSEP-363856 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new medication to see if it changes how long it takes food to move through the stomach into the small intestine in people with schizophrenia. It is open to both male and female participants and will last about 10 weeks.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 4 hours post-radiolabel meal on dosing Day 1 and 2

Day 1
Gastric retention at 2 hr post-radiolabeled meal (gastric emptying scintigraphy (GES) imaging)
Day 1
Gastric retention at 4 hr post-radiolabeled meal (gastric emptying scintigraphy (GES) imaging)
Day 1
Gastric emptying T 1/2 (gastric emptying scintigraphy (GES) imaging)

Trial Safety

Safety Progress

1 of 3

Side Effects for

SEP-363856
9%Headache
7%Somnolence
6%Schizophrenia
5%Nausea
5%Agitation
3%Insomnia
2%Anxiety
1%Cardiovascular insufficiency
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02969382) in the SEP-363856 ARM group. Side effects include: Headache with 9%, Somnolence with 7%, Schizophrenia with 6%, Nausea with 5%, Agitation with 5%.

Trial Design

2 Treatment Groups

Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)
1 of 2
SEP-363856
1 of 2

Active Control

Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: SEP-363856 · No Placebo Group · Phase 1

SEP-363856
Drug
Experimental Group · 1 Intervention: SEP-363856 · Intervention Types: Drug
Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)
Drug
ActiveComparator Group · 1 Intervention: Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole) · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEP-363856
2016
Completed Phase 2
~700

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 hours post-radiolabel meal on dosing day 1 and 2

Who is running the clinical trial?

SunovionLead Sponsor
188 Previous Clinical Trials
47,883 Total Patients Enrolled
44 Trials studying Schizophrenia
11,719 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy DirectorSunovion
30 Previous Clinical Trials
6,450 Total Patients Enrolled
12 Trials studying Schizophrenia
2,641 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The criteria for inclusion in this study are:\n- Patient must be 18 years or older.
You are between 18 and 65 years of age.
You have a CGI-S score of ≤ 4 (normal to moderately ill) at Screening.
You have a score of ≤ 80 on the PANSS total score and a score of ≤ 4 on the following PANSS items: P7 (hostility) and G8 (uncooperativeness).
Subjects must have been taking antipsychotic medication for at least eight weeks prior to the Screening visit.