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

Concert Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: CTP-692

Study type: Interventional

Funder types: Industry

Identifiers

NCT04158687

CP692.2001

Details and patient eligibility

About

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

Enrollment: 326 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physician confirmed diagnostic and statistical manual-version 5 (DSM-V5) diagnosis of schizophrenia for the past 2 years
• Patients with clinically stable schizophrenia with residual symptoms defined as positive and negative syndrome scale (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-V5 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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326 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received CTP-692 matched-placebo powder for oral solution, once daily (QD) for up to 12 weeks.

Treatment:

Drug: Placebo

CTP-692 1 gram QD

Experimental group

Description:

Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks.

Treatment:

Drug: CTP-692

CTP-692 2 grams QD

Experimental group

Description:

Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks.

Treatment:

Drug: CTP-692

CTP-692 4 grams QD

Experimental group

Description:

Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks.

Treatment:

Drug: CTP-692