ACTIVE_NOT_RECRUITING

Study of SPG302 in Adults With Schizophrenia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Randomized, Placebo-controlled, Double-blind Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacodynamics of SPG302 in Adult Participants Diagnosed With Schizophrenia

Quick Facts

Study Start:2024-08-01
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06442462

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-65
  2. * Primary diagnosis of schizophrenia
  3. * Clinical laboratory values within normal range or \< 1.5 times ULN
  4. * Currently prescribed only one antipsychotic medication, with stable dose for at least 4 weeks
  5. * Able and willing to provide written informed consent
  1. * Any physical or psychological condition that prohibits study completion
  2. * Known cardiac disease
  3. * Active or history of malignancy in the past 5 years
  4. * History of clinically significant CNS event or diagnosis in the past 5 years.
  5. * Receipt of investigational products within 30 days
  6. * Blood donation within 30 days

Contacts and Locations

Principal Investigator

David Walling, MD
PRINCIPAL_INVESTIGATOR
CenExel

Study Locations (Sites)

CenExel CNS
Garden Grove, California, 92845
United States

Collaborators and Investigators

Sponsor: Spinogenix

  • David Walling, MD, PRINCIPAL_INVESTIGATOR, CenExel

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • synaptogenesis
  • synapse
  • dendritic spines

Additional Relevant MeSH Terms

  • Schizophrenia