Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
32 participants
INTERVENTIONAL
2024-08-01
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia
NCT00063297
A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia
NCT04510298
Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo
NCT00570063
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects With Schizophrenia
NCT01095562
SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia
NCT01234298
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will entail weekly visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active SPG302 to be administered to participants with Schizophrenia
Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.
SPG302
small synthetic molecule
Placebo comparator to be administered to participants with Schizophrenia
Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPG302
small synthetic molecule
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Primary diagnosis of schizophrenia
* Clinical laboratory values within normal range or \< 1.5 times ULN
* Currently prescribed only one antipsychotic medication, with stable dose for at least 4 weeks
* Able and willing to provide written informed consent
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Spinogenix
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Walling, MD
Role: PRINCIPAL_INVESTIGATOR
CenExel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CenExel CNS
Garden Grove, California, United States
Box Hill Hospital - Eastern Health
Box Hill, Victoria, Australia
Multidisciplinary Alfred Psychiatry Research Centre (MAPrc)
Melbourne, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPG302-SCZ-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.