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

• Sponsor: Concert Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04158687
• Collaborator: Cognitive Research Corporation (Industry)
• Enrollment: 326
• Locations: 24
• Arms: 4
• Actual Duration (Months): 12.9
• Patients Per Site: 13.6
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: CTP-692; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 326 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: Nov 26, 2019
• Actual Primary Completion Date: Dec 16, 2020
• Actual Study Completion Date: Dec 22, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woodland International Research Group, LLC	Little Rock	Arkansas	United States	72211
2	Woodland Research Northwest, LLC	Rogers	Arkansas	United States	72758
3	Synexus Clinical Research US, Inc.	Cerritos	California	United States	90703
4	ProScience Research Group	Culver City	California	United States	90230
5	Collaborative Neuroscience Network, LLC	Garden Grove	California	United States	92845
6	Synergy San Diego	Lemon Grove	California	United States	91945
7	Pacific Research Partners, LLC	Oakland	California	United States	94607
8	Collaborative Neuroscience Network, LLC	Torrance	California	United States	90502
9	Innovative Clinical Research, Inc.	Lauderhill	Florida	United States	33319
10	Behavioral Clinical Research, Inc.	North Miami	Florida	United States	33161
11	Synexus Clinical Research US, Inc.	Atlanta	Georgia	United States	30328
12	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30331
13	Uptown Research Institute, LLC	Chicago	Illinois	United States	60640
14	Pillar Clinical Research, LLC	Lincolnwood	Illinois	United States	60712
15	CBH Health, LLC	Gaithersburg	Maryland	United States	20877
16	Arch Clinical Trials, LLC	Saint Louis	Missouri	United States	63118
17	Hassman Research Institute	Berlin	New Jersey	United States	08009
18	Hassman Research Institute	Marlton	New Jersey	United States	08053
19	Neurobehavioral Research, Inc.	Cedarhurst	New York	United States	11516
20	Synexus Clinical Research US, Inc.	Jamaica	New York	United States	11432
21	Donald J. Garcia Jr., MD, PA	Austin	Texas	United States	78737
22	Community Clinical Research, Inc.	Austin	Texas	United States	78754
23	InSite Clinical Research, LLC	DeSoto	Texas	United States	75115
24	Pillar Clinical Research, LLC	Richardson	Texas	United States	75080

Sponsors and Collaborators

• Concert Pharmaceuticals
• Cognitive Research Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Concert Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04158687
• Other Study ID Numbers: CP692.2001
• First Posted: Nov 12, 2019
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Dec 17, 2021