SEP-363856 for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Galiz Research, Hialeah, FL
Schizophrenia
SEP-363856 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia and assess whether it changes: how the body processes (uses) glucose (blood sugar) how much insulin the pancreas can make. Insulin is a hormone that lowers blood sugar levels in the body. The information from this study will help to understand any effect the study medication may have on how the body uses and stores glucose. This study is accepting both male and female subjects. It will be held in approximately 6 locations in the United States. Participation could last up to 12 weeks.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Schizophrenia

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)

Day 48
Change from baseline (PA) in mixed meal tolerance test (MMTT) derived plasma AUC0-240 min of glucose, insulin, c-peptide and β-cell responsivity index to stable dose (SEP-363856) period assessment.
Change from baseline (PA) in oGTT derived plasma AUC0-120 min of glucose, insulin, c-peptide in oGTT to stable dose (SEP-363856) period assessment.
Change from baseline (PA) in plasma AUC0-240 min
Change in Cmax of acetaminophen levels to stable dose (SEP-363856) period assessment.
Change in gastric emptying terminal elimination half-life (T1/2), baseline to stable dose (SEP-363856) period assessment.
Change in kPCD, baseline to stable dose (SEP-363856) period assessment
Change in the Visual Analog Scale (VAS) of fullness, hunger and satiety, baseline - repeat test (PA baseline to SEP-363856 stable dose period assessment) for all time points.
Day 48
Change in lag time, baseline to stable dose (SEP-363856) period assessment

Trial Safety

Safety Progress

1 of 3

Other trials for Schizophrenia

Side Effects for

SEP-363856
9%Headache
7%Somnolence
6%Schizophrenia
5%Nausea
5%Agitation
3%Insomnia
2%Anxiety
1%Cardiovascular insufficiency
0%Suicide attempt
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

1 Treatment Group

SEP-363856
1 of 1
Experimental Treatment

24 Total Participants · 1 Treatment Group

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

SEP-363856
Drug
Experimental Group · 1 Intervention: SEP-363856 · 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

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pa baseline and sep-363856 stable dose period (up to 48 days)
Closest Location: Galiz Research · Hialeah, FL
Photo of Hialeah 1Photo of florida 2Photo of florida 3
2009First Recorded Clinical Trial
11 TrialsResearching Schizophrenia
34 CompletedClinical Trials

Who is running the clinical trial?

SunovionLead Sponsor
186 Previous Clinical Trials
46,912 Total Patients Enrolled
43 Trials studying Schizophrenia
11,611 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy DirectorSunovion
28 Previous Clinical Trials
6,081 Total Patients Enrolled
10 Trials studying Schizophrenia
2,473 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.