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A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia

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ClinicalTrials.gov Identifier: NCT04158687
Recruitment Status : Recruiting
First Posted : November 11, 2019
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
Cognitive Research Corporation
Information provided by (Responsible Party):
Concert Pharmaceuticals

Brief Summary:
The objective of this study is to assess the safety and efficacy of 3 different doses of CTP-692 administered once daily for 12 weeks to adult patients with schizophrenia on stable dopaminergic antipsychotic medication.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: CTP-692 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adult Patients With Schizophrenia
Actual Study Start Date : November 26, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 1 g CTP-692
Powder for oral solution, taken once daily
Drug: CTP-692
CTP-692 taken orally

Experimental: 2 g CTP-692
Powder for oral solution, taken once daily
Drug: CTP-692
CTP-692 taken orally

Experimental: 4 g CTP-692
Powder for oral solution, taken once daily
Drug: CTP-692
CTP-692 taken orally

Placebo Comparator: Placebo
Powder for oral solution, taken once daily
Drug: Placebo
Placebo taken orally




Primary Outcome Measures :
  1. Change in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: 12 weeks ]
    PANSS measures symptom severity in patients with schizophrenia. PANSS includes 30 items (7 items for positive symptoms, 7 items for negative symptoms, and 16 items for general psychopathology symptoms), and each item ranges from 1 to 7. The PANSS total score is a sum of scores from all items, ranging from 30 to 210, where a higher score represents more severe psychotic symptoms in patients with schizophrenia.


Secondary Outcome Measures :
  1. Change in Clinical Global Impression-Severity (CGI-S) score [ Time Frame: 12 weeks ]
    The CGI-S score ranges from 1 to 7. A higher score represents a more severe clinical impression on the patient's severity based on investigator/clinician's judgment.

  2. Change in Personal and Social Performance (PSP) Scale [ Time Frame: 12 weeks ]
    The PSP contains four domains: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. A higher domain score represents worse functional performance in each domain. The final global score is defined according to a summary instruction table converting four domain scores into a single, overall rating from 1 to 100, where a higher score represents better personal and social function.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years
  • Patients with clinically stable schizophrenia with residual symptoms defined as PANSS total score of 70-110
  • Patients currently treated with one antipsychotic medication

Exclusion Criteria:

  • Patients who, in the opinion of the Investigator, have a history of antipsychotic treatment resistance
  • Patients currently taking clozapine
  • History of meeting DSM-5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before the first Screening Visit
  • Patients with positive blood screen for human immunodeficiency virus (HIV antibody) and/or hepatitis B virus surface antigen
  • Patients with history of renal disease or those taking medications to treat renal disease

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): NCT04158687


Contacts
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Contact: Vinita Uttamsingh, Ph.D. 781-674-5240 CNSclinicaltrial_inquiries@concertpharma.com

Locations
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United States, Arkansas
Woodland International Research Group, LLC Recruiting
Little Rock, Arkansas, United States, 72211
Woodland Research Northwest, LLC Recruiting
Rogers, Arkansas, United States, 72758
United States, California
Synexus Clinical Research US, Inc. Recruiting
Cerritos, California, United States, 90703
ProScience Research Group Recruiting
Culver City, California, United States, 90230
Collaborative Neuroscience Network, LLC Recruiting
Garden Grove, California, United States, 92845
Synergy San Diego Recruiting
Lemon Grove, California, United States, 91945
Pacific Research Partners, LLC Recruiting
Oakland, California, United States, 94607
Collaborative Neuroscience Network, LLC Recruiting
Torrance, California, United States, 90502
United States, Florida
Innovative Clinical Research, Inc. Recruiting
Lauderhill, Florida, United States, 33319
Behavioral Clinical Research, Inc. Recruiting
North Miami, Florida, United States, 33161
United States, Georgia
Synexus Clinical Research US, Inc. Recruiting
Atlanta, Georgia, United States, 30328
United States, Illinois
Uptown Research Institute, LLC Recruiting
Chicago, Illinois, United States, 60640
United States, Maryland
CBH Health, LLC Recruiting
Gaithersburg, Maryland, United States, 20877
United States, Nevada
Altea Research Institute Recruiting
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Hassman Research Institute Recruiting
Berlin, New Jersey, United States, 08009
Hassman Research Institute Recruiting
Marlton, New Jersey, United States, 08053
United States, New York
Neurobehavioral Research, Inc. Recruiting
Cedarhurst, New York, United States, 11516
Synexus Clinical Research US, Inc. Recruiting
Jamaica, New York, United States, 11432
United States, South Carolina
Carolina Clinical Trials, Inc. Recruiting
Charleston, South Carolina, United States, 29407
United States, Texas
Donald J. Garcia Jr., MD, PA Recruiting
Austin, Texas, United States, 78737
Community Clinical Research, Inc. Recruiting
Austin, Texas, United States, 78754
InSite Clinical Research, LLC Recruiting
DeSoto, Texas, United States, 75115
Sponsors and Collaborators
Concert Pharmaceuticals
Cognitive Research Corporation

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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04158687     History of Changes
Other Study ID Numbers: CP692.2001
First Posted: November 11, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders