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.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2016-11-30
2018-11-02
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.
Phase I Study to Evaluate the Safety and Pharmacokinetics of Oral Doses of Anvylic-3288 in Healthy Subjects
NCT01851603
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia
NCT05545111
A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
NCT07145918
Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
NCT07288333
Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia
NCT04461119
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AVL-3288 10 mg
AVL-3288 10 mg daily for 5 days
AVL-3288
daily for 5 days
AVL-3288 30 mg
AVL-3288 30 mg daily for 5 days
AVL-3288
daily for 5 days
Placebo
Placebo daily for 5 days
Placebo
daily for 5 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AVL-3288
daily for 5 days
Placebo
daily for 5 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* RBANS Total Scale Score \>62
* Willing to provide informed consent
* Medically stable for study participation
* Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks
* Judged clinically not to be at significant suicide or violence risk
Exclusion Criteria
* ECG abnormality that is clinically significant
* Current clozapine use
* Participation in a study of investigational medication/device within 4 weeks
* Pregnancy, lactation, or lack of use of effective birth control
* Active tobacco use
* Presence or positive history of significant medical or neurological illness, including cardiac illness, WBC \<3500/mm3, absolute neutrophil count \<1500/mm3, ALT or AST values \>1.5 times upper limit of normal. Hemoglobin less than 130 g/L (13 g/dL) in males or 120 g/L (12 g/dL) in females or known HIV +
* Contraindication to MRI scanning, including metal implants or claustrophobia
* Medicinal patch, unless removed
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joshua Kantrowitz
Assistant Professor of Clinical Psychiatry
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffrey A Lieberman, MD
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
New York State Psychiatric Institute
New York, New York, United States
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.
7370
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.