Study of SPG302 in Adults With Schizophrenia

Spinogenix

Status and phase: Enrolling; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: SPG302

Study type: Interventional

Funder types: Industry

Identifiers

NCT06442462

SPG302-SCZ-201

Details and patient eligibility

About

This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.

Full description

This Phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia. This is a randomized, placebo-controlled study of SPG302 administered once daily for six weeks.

This study will entail five visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-65
• Primary diagnosis of schizophrenia
• Clinical laboratory values within normal range or < 1.5 times ULN
• Currently prescribed only one antipsychotic medication
• Able and willing to provide written informed consent

Exclusion criteria

• Any physical or psychological condition that prohibits study completion
• Known cardiac disease
• Active or history of malignancy in the past 5 years
• History of clinically significant CNS event or diagnosis in the past 5 years.
• Receipt of investigational products within 30 days
• Blood donation within 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

32 participants in 2 patient groups, including a placebo group

Active SPG302 to be administered to participants with Schizophrenia

Active Comparator group

Description:

Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.

Treatment:

Drug: SPG302

Placebo comparator to be administered to participants with Schizophrenia

Placebo Comparator group

Description:

Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.

Treatment:

Drug: Placebo