Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02970929
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sunovion

Brief Summary:
An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: SEP-363856 Phase 2

Detailed Description:

This is a 26 week, multiregional, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 for the treatment of subjects with schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201.

No statistical hypothesis tests will be performed.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects With Schizophrenia
Actual Study Start Date : January 31, 2017
Actual Primary Completion Date : January 29, 2019
Actual Study Completion Date : January 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: SEP-363856
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
Drug: SEP-363856
One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks




Primary Outcome Measures :
  1. The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation [ Time Frame: 27 weeks ]

Secondary Outcome Measures :
  1. Absolute values from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361-202 in clinical laboratory tests (hematology) [ Time Frame: 26 weeks ]
  2. Changes from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361 202 in clinical laboratory tests (hematology) [ Time Frame: 26 weeks ]
  3. Changes from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361-202 in clinical laboratory tests (serum chemistry) [ Time Frame: 26 weeks ]
  4. Absolute values from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361-202 in clinical laboratory tests (serum chemistry) [ Time Frame: 26 weeks ]
  5. Changes from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361-202 in clinical laboratory tests (urinalysis) [ Time Frame: 26 weeks ]
  6. Absolute values from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361-202 in clinical laboratory tests (urinalysis) [ Time Frame: 26 weeks ]
  7. Changes from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361-202 in clinical laboratory tests (glucose and lipid panel) [ Time Frame: 26 weeks ]
  8. Absolute values from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361 202 in clinical laboratory tests (glucose and lipid panel) [ Time Frame: 26 weeks ]
  9. Changes from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361-202 in clinical laboratory tests (prolactin) [ Time Frame: 26 weeks ]
  10. Absolute values from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361-202 in clinical laboratory tests (prolactin) [ Time Frame: 26 weeks ]
  11. Changes from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361-202 in clinical laboratory tests (glycosylated hemoglobin (HbA1c)) [ Time Frame: 26 weeks ]
  12. Absolute values from double-blind (DB) Baseline of Study SEP361-201 and open-label (OL) Baseline of Study SEP361-202 in clinical laboratory tests (glycosylated hemoglobin (HbA1c)) [ Time Frame: 26 weeks ]
  13. Changes from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (vital signs) [ Time Frame: 27 weeks ]
  14. Absolute values from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (vital signs) [ Time Frame: 27 weeks ]
  15. Changes from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (body weight) [ Time Frame: 26 weeks ]
  16. Absolute values from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (body weight) [ Time Frame: 26 weeks ]
  17. Changes from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (BMI) [ Time Frame: 26 weeks ]
  18. Absolute values from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (BMI) [ Time Frame: 26 weeks ]
  19. Changes from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (blood pressure [supine and standing]). [ Time Frame: 27 weeks ]
  20. Absolute values from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (blood pressure [supine and standing]). [ Time Frame: 27 weeks ]
  21. Changes from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (heart rate [supine and standing]) [ Time Frame: 27 weeks ]
  22. Absolute values from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (heart rate [supine and standing]) [ Time Frame: 27 weeks ]
  23. Changes from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (12 lead ECGs) [ Time Frame: 26 weeks ]
  24. Absolute values from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in clinical evaluations (12 lead ECGs) [ Time Frame: 26 weeks ]
  25. Severity of suicidal ideation and suicidal behavior using the C-SSRS [ Time Frame: 27 weeks ]
  26. Frequency of suicidal ideation and suicidal behavior using the Columbia - Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 27 weeks ]
  27. time to relapse during the 26 week OL period for subjects who demonstrated a clinical response to 4 weeks of treatment with SEP-363856. [ Time Frame: 26 weeks ]

    Relapse will be defined as the onset of any of the following:

    • An increase in PANSS total score ≥ 30% from the PANSS total score at clinical response and a CGI S score ≥ 3
    • Re-hospitalization for worsening of psychosis
    • Emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others.

  28. Rate of relapse during the 26 week OL period for subjects who demonstrated a clinical response to 4 weeks of treatment with SEP-363856. [ Time Frame: 26 weeks ]

    Relapse will be defined as the onset of any of the following:

    • An increase in PANSS total score ≥ 30% from the PANSS total score at clinical response and a CGI S score ≥ 3
    • Re-hospitalization for worsening of psychosis
    • Emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others.

  29. Changes from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in Positive and negative syndrome scale (PANSS) total score and subscale scores (positive, negative, and general psychopathology) [ Time Frame: 26 weeks ]
  30. Change from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in Clinical global impression - severity (CGI-S) score. [ Time Frame: 26 weeks ]
  31. Change from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361 202 in Brief Negative Symptom Scale (BNSS) total score. [ Time Frame: 26 weeks ]
  32. Change from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. [ Time Frame: 26 weeks ]
  33. Proportion of subjects who achieve a response, defined as a 20% or greater improvement in PANSS total score from the baseline [ Time Frame: 26 weeks ]
    calculated using (1) the DB Baseline of Study SEP361-201 for subjects assigned to double-blind SEP-363856, and (2) the OL Baseline of Study SEP361-202 for subjects assigned to double blind placebo.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subject must give written informed consent and privacy authorization prior to participation in the study and able to comply with the protocol, in the opinion of the investigator.

  • Subject has completed Study SEP361 201 through Week 4
  • Subject has not taken any medication other than the study drug for the purpose of controlling schizophrenia symptoms during Study SEP361 201.
  • Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361 201; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
  • Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until at least 30 days after the last study drug administration

Exclusion Criteria:

  • Subject answers "yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Visit 7 of Study SEP361 201. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
  • Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
  • Subject has a positive urine drug screen (UDS) or breath alcohol test at Visit 7 of Study SEP361 201.
  • Subject is pregnant or lactating.
  • Subject is at high risk of non-compliance in the Investigator's opinion.
  • Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970929


Locations
Show Show 29 study locations
Sponsors and Collaborators
Sunovion
Investigators
Layout table for investigator information
Study Chair: CNS Medical Director Sunovion
Layout table for additonal information
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02970929    
Other Study ID Numbers: SEP361-202
2016-001556-21 ( EudraCT Number )
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunovion:
Schizophrenia
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders