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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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CTP-692
Placebo
Sponsored by
Concert Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Woodland International Research Group, LLC
  • Woodland Research Northwest, LLC
  • Synexus Clinical Research US, Inc.
  • ProScience Research Group
  • Collaborative Neuroscience Network, LLC
  • Synergy San Diego
  • Pacific Research Partners, LLC
  • Collaborative Neuroscience Network, LLC
  • Innovative Clinical Research, Inc.
  • Behavioral Clinical Research, Inc.
  • Synexus Clinical Research US, Inc.
  • Atlanta Center for Medical Research
  • Uptown Research Institute, LLC
  • Pillar Clinical Research, LLC
  • CBH Health, LLC
  • Arch Clinical Trials, LLC
  • Hassman Research Institute
  • Hassman Research Institute
  • Neurobehavioral Research, Inc.
  • Synexus Clinical Research US, Inc.
  • Donald J. Garcia Jr., MD, PA
  • Community Clinical Research, Inc.
  • InSite Clinical Research, LLC
  • Pillar Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1 g CTP-692

2 g CTP-692

4 g CTP-692

Placebo

Arm Description

Powder for oral solution, taken once daily

Powder for oral solution, taken once daily

Powder for oral solution, taken once daily

Powder for oral solution, taken once daily

Outcomes

Primary Outcome Measures

Change in Positive and Negative Syndrome Scale (PANSS) total score
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

Change in Clinical Global Impression-Severity (CGI-S) score
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.
Change in Personal and Social Performance (PSP) Scale
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.

Full Information

First Posted
November 7, 2019
Last Updated
December 13, 2021
Sponsor
Concert Pharmaceuticals
Collaborators
Cognitive Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04158687
Brief Title
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 26, 2019 (Actual)
Primary Completion Date
December 16, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concert Pharmaceuticals
Collaborators
Cognitive Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 g CTP-692
Arm Type
Experimental
Arm Description
Powder for oral solution, taken once daily
Arm Title
2 g CTP-692
Arm Type
Experimental
Arm Description
Powder for oral solution, taken once daily
Arm Title
4 g CTP-692
Arm Type
Experimental
Arm Description
Powder for oral solution, taken once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Powder for oral solution, taken once daily
Intervention Type
Drug
Intervention Name(s)
CTP-692
Intervention Description
CTP-692 taken orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo taken orally
Primary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS) total score
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression-Severity (CGI-S) score
Description
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.
Time Frame
12 weeks
Title
Change in Personal and Social Performance (PSP) Scale
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Woodland International Research Group, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland Research Northwest, LLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Pacific Research Partners, LLC
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Innovative Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Behavioral Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Uptown Research Institute, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Lincolnwood
State/Province
Illinois
ZIP/Postal Code
60712
Country
United States
Facility Name
CBH Health, LLC
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Arch Clinical Trials, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Hassman Research Institute
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Donald J. Garcia Jr., MD, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
InSite Clinical Research, LLC
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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