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Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia

2014-07-24 14:11:40 | BioPortfolio

Summary

This study is being conducted to determine the safety and tolerability of two different doses of an investigational medication, EVP-6124, in individuals with schizophrenia who are on chronic stable atypical anti-psychotic therapy. In addition, cognitive performance and behavioral and psychotic symptoms will be evaluated.

Description

This is a randomized, double-blind, placebo-controlled, Phase 2 safety/efficacy study in which two dose levels of EVP-6124 will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for schizophrenia and who are taking chronic atypical anti-psychotic medication at a stable dose. This study will therefore evaluate the effects of EVP-6124 when administered concomitantly with anti-psychotic medication.

Patients will be randomized to one of the following groups: 0.3 mg or 1.0 mg EVP-6124, or placebo. Seventy-five patients per group. Study drug will be supplied as capsules and will be orally administered once daily for a total of 84 days.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Schizophrenia

Intervention

EVP-6124, Placebo

Status

Not yet recruiting

Source

EnVivo Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:11:40-0400

Clinical Trials [989 Associated Clinical Trials listed on BioPortfolio]

A 26-Week Extension Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy

This study is being conducted to further investigate the safety of prolonged exposure to EVP-6124 in subjects with Schizophrenia receiving a stable dose of an atypical antipsychotic who co...

Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy

The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic th...

Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy

The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic th...

A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence

This study is designed to evaluate the initial evidence for efficacy of the investigational medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper of n...

Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease

This study is being conducted to determine the safety and tolerability of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.

PubMed Articles [1683 Associated PubMed Articles listed on BioPortfolio]

Nicotinic alpha 7 receptor agonists EVP-6124 and BMS-933043, attenuate scopolamine-induced deficits in visuo-spatial paired associates learning.

Agonists at the nicotinic acetylcholine alpha 7 receptor (nAChR α7) subtype have the potential to treat cognitive deficits in patients with Alzheimer's disease (AD) or schizophrenia. Visuo-spatial pa...

Statin add-on therapy in the antipsychotic treatment of schizophrenia: A meta-analysis.

A comprehensive meta-analysis of statin add-on therapy in the antipsychotic treatment of schizophrenia was conducted. Data from previous studies, prior to 8/21/2017, was obtained from Scopus, PubMed, ...

Predictors of Placebo Response in Pharmacological Clinical Trials of Negative Symptoms in Schizophrenia: A Meta-regression Analysis.

We conducted a meta-regression analysis of all double-blind, randomized, placebo-controlled clinical trials (DBRCTs) reporting effects of drug and placebo on negative symptoms in people with stable sc...

L-carnosine as an add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: A double-blind, randomized placebo-controlled trial.

Since l-carnosine has shown effectiveness in improvement of cognition in patients with schizophrenia, this 8-week, randomized, double-blind, placebo-controlled pilot study was conducted. Sixty-three p...

Adjunctive therapy with statins in schizophrenia patients: A meta-analysis and implications.

There are some conflicting results regarding the benefit of adjunctive therapy with statins for severity of negative symptoms in schizophrenia. This study aimed to verify whether statins use for adjun...

Medical and Biotech [MESH] Definitions

A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.

A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.

An obsolete concept, historically used for childhood mental disorders thought to be a form of schizophrenia.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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