Clinical Trial of AVL-3288 in Schizophrenia Patients
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 1/23/2019 |
| Start Date: | November 2016 |
| End Date: | November 2, 2018 |
Double Blind, Two Dose, Cross-over Clinical Trial of the Positive Allosteric Modulator at the alpha7 Nicotinic Cholinergic Receptor AVL-3288 in Schizophrenia Patients
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.
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.
This study will be in 24 non-smoking outpatients with schizophrenia or schizoaffective
disorder. Subjects will complete three treatment phases, each involving 5 straight days of
taking AVL-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in
which subjects do not take the study drug to ensure that the drug is completed eliminated
from the body before the next phase.
disorder. Subjects will complete three treatment phases, each involving 5 straight days of
taking AVL-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in
which subjects do not take the study drug to ensure that the drug is completed eliminated
from the body before the next phase.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
New York, New York 10032
646-774-5000
Principal Investigator: Joshua T Kantrowitz, MD
Phone: 646-774-8436
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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