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A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369391
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Sunovion

Brief Summary:
A clinical study to investigate the effect of an investigational drug in adults with schizophrenia by using Electrocardiogram (Picture of the electrical action of the heart). This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 7 locations in the US. The study will last approximately 7 weeks.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: SEP363856 150 mg Drug: Placebo Drug: moxifloxacin 400 mg Phase 1

Detailed Description:

This is a Phase 1, randomized, single-dose, active and placebo controlled, 3-period crossover study of the effect of SEP-363856 150 mg on electrocardiogram (ECG) intervals in subjects with schizophrenia. SEP-363856 and matching placebo will be utilized in a double-blind fashion. Moxifloxacin will be utilized as an active control in an open-label fashion.

The primary analysis will be based on concentration-QTc modeling of the relationship between plasma concentrations of SEP-363856 or its metabolite SEP-363854 and change-from baseline QTc.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Subjects will be randomized using a double Williams design in equal ratio to six possible sequences of receiving the three treatments being studied:

SEP-363856 150mg, Matched Placebo, moxifloxacin 400mg.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Blinded
Primary Purpose: Treatment
Official Title: A Randomized, Single-dose, Crossover Study of the Effects of SEP-363856 on Electrocardiogram (ECG) Intervals in Subjects With Schizophrenia
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : November 2, 2020
Estimated Study Completion Date : November 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: SEP363856 150 mg
SEP363856 tablet 150 mg
Drug: SEP363856 150 mg
SEP363856 tablet 150 mg

Placebo Comparator: Placebo
matched placebo
Drug: Placebo
Placebo tablet

Active Comparator: moxifloxacin 400 mg
moxifloxacin tablet 400 mg
Drug: moxifloxacin 400 mg
moxifloxacin tablet 400 mg




Primary Outcome Measures :
  1. Placebo-adjusted change-from-baseline QTc interval (ΔΔQTc) [ Time Frame: 24 Hours ]

Secondary Outcome Measures :
  1. Change from baseline in heart rate, QTcF, pulse rate, and QRS intervals (∆HR, ΔQTcF, ΔPR, and ∆QRS) [ Time Frame: 24 Hours ]
  2. If a substantial heart rate (HR) effect is observed: Change from baseline in QTcS, QTcI, and QTcP (ΔQTcS, ΔQTcI, and ΔQTcP) [ Time Frame: 24 Hours ]
  3. Placebo-adjusted change from baseline in heart rate, pulse rate, and QRS intervals (ΔΔHR, ΔΔPR, and ΔΔQRS) [ Time Frame: 24 Hours ]
  4. If a substantial heart rate (HR) effect is observed: Placebo-adjusted ΔQTcS, and/or ΔQTcI, and/or ΔQTcP, and/or ΔQTcF (ΔΔQTcS, ΔΔQTcI, ΔΔQTcP, ΔΔQTcF) if not selected as the primary endpoint [ Time Frame: 24 Hours ]
  5. Categorical summary for QTcF, heart rate, pulse rate, and QRS intervals [ Time Frame: 24 Hours ]
  6. If a substantial heart rate (HR) effect is observed: Categorical summary for QTcS, QTcI, and QTcP [ Time Frame: 24 Hours ]
  7. Frequency of treatment-emergent changes of T-wave morphology and U-waves presence. [ Time Frame: 24 Hours ]


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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject between 18 and 65 years of age, inclusive, at the time of informed consent
  • Subject must give written informed consent and privacy authorization prior to participation in the study
  • Subject meets DSM-5 criteria for a primary diagnosis of schizophrenia as established by clinical interview
  • Subject must have a CGI S score ≤ 4 at Screening
  • Subject must have a PANSS total score ≤ 80 at Screening
  • Subject must have a score of ≤ 4 on the following PANSS items at Screening:

    • P7 (hostility)
    • G8 (uncooperativeness)
  • Subject must have normal to mild symptoms on all individual items of the SAS (< 2), AIMS (< 3) and BARS (< 3) at Screening
  • Subject must be clinically stable for the past three months in the opinion of the Investigator
  • Subject has been taking an antipsychotic for at least six weeks prior to Screening and has had no change in antipsychotic medication(s) for at least six weeks prior to Screening
  • Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, physical examination, neurological examination, vital sign measurement, electrocardiogram and clinical laboratory values

Exclusion Criteria:

  • Subject has a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment
  • Subject tests positive for drugs of abuse or alcohol at Screening
  • Subject is at significant risk of harming him/herself or others (passive or active) according to the Investigator's judgment.
  • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study
  • Female subject who is pregnant or lactating
  • Subject has any clinically significant abnormal laboratory value(s) at Screening as judged by the Investigator
  • Subject has an abnormal, clinically significant 12-lead ECG at screening
  • Subject has experienced significant blood loss (≥ 473 mL) or donated blood within 60 days prior to first dose of study drug; has donated plasma within 72 hours prior to the first dose of study drug or intends to donate plasma or blood or undergo elective surgery during study participation or within 60 days after the last study visit.
  • Subject has an abnormal, clinically significant 12-lead ECG at screening
  • Subject has a history of sick sinus syndrome, first, second, or third-degree AV block,myocardial infarction, NYHA Class II-IV heart failure, cardiomyopathy, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia

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): NCT04369391


Contacts
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Contact: CNS Medical Director 1-866-503-6351 ClinicalTrialDisclosure@sunovion.com

Locations
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United States, Arkansas
Woodland International Research Group Recruiting
Little Rock, Arkansas, United States, 72211
Contact: George Konis, MD    501-221-8681      
United States, California
Collaborative Neuroscience Research, LLC Recruiting
Long Beach, California, United States, 90806
Contact: David Walling, PhD    562-304-1742 ext 4745      
California Neuropsychopharmacology Clinical Research Institute-LA, LLC (CNRI-LA, LLC) Recruiting
Pico Rivera, California, United States, 90660
Contact: Raymond A Manning, MD    562-928-8601      
California Neuropsychopharmacology Clinical Research Institute-San Diego, LLC (CNRI-SD, LLC) Recruiting
San Diego, California, United States, 92101
Contact: Christopher Benbow, MD    619-481-5252      
United States, Florida
Research Centers of America, LLC Recruiting
Hollywood, Florida, United States, 33024
Contact: Peter P. Ventre, MD    954-734-2294      
United States, New Jersey
Hassman Research Institute Recruiting
Marlton, New Jersey, United States, 08053
Contact: Howard Hassman, DO    856-452-9901      
United States, Texas
Community Clinical Research Inc. Austin, TX 78754 Recruiting
Austin, Texas, United States, 78754
Contact: David Brown, MD    512-597-6714      
Sponsors and Collaborators
Sunovion
Investigators
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Study Chair: CNS Medical Director Sunovion
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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT04369391    
Other Study ID Numbers: SEP361-114
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study may be made available upon request via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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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:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents