Clinical Trial of AVL-3288 in Schizophrenia Patients
Completed · Phase 1 · Has a placebo group
Conditions studied: Schizophrenia, Schizoaffective Disorder
In brief
Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase, cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of AVL-3288 each compared to placebo, in patients with schizophrenia.
Key facts
- Study ID
- NCT02978599
- Run by
- New York State Psychiatric Institute
- People needed
- 24
- Starts
- 2016-11-01
- Expected to finish
- 2018-11-02
- Last updated by the study team
- 2019-01-22
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- DSM-V diagnosis of schizophrenia or schizoaffective disorder
- 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
You may not qualify if…
- Substance abuse (excluding nicotine) within last 90 days
- 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
Where it is running
- New York State Psychiatric Institute — New York, New York, United States
Full record on ClinicalTrials.gov
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