Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia
NCT ID: NCT00968851
Last Updated: 2014-04-25
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
PHASE2
317 participants
INTERVENTIONAL
2009-12-31
2011-03-31
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.
Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy
NCT01716975
Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy
NCT01714661
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
NCT01714713
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia
NCT01556763
Study to Assess the Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Effects of EVP-6308 and the Potential of EVP-6308 to Affect the PK Properties of the Antipsychotic Regimen in Subjects With Schizophrenia Currently Receiving Stable Treatment With up to 2 Atypical Antipsychotics
NCT02037074
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
EVP-6124 0.3 mg
one 0.3 mg capsule every day for 84 days
EVP-6124
Arms: 1
EVP-6124 1.0 mg
one 1.0 mg capsule every day for 84 days.
EVP-6124
Arms: 2
Placebo
Placebo every day for 84 days
Placebo
Arm: 3
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EVP-6124
Arms: 1
Placebo
Arm: 3
EVP-6124
Arms: 2
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks
* Must have no more than "moderate" severity rating for negative symptoms: BPRS item ≤4
* A minimal level of extrapyramidal symptoms (EPS); Simpson-Angus Scale total score ≤6
* A minimal level of depression; Calgary Depression Scale total score ≤10
* Must have a general health status acceptable for participation in a 12-week clinical trial
* Fluency (oral and written) in the language in which the standardized tests will be administered
* If a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing
Exclusion Criteria
* Insufficiently controlled diabetes mellitus in the judgment of the investigator
* Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ
* Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
* Unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Syneos Health
OTHER
FORUM Pharmaceuticals Inc
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.
Chris Southard
Role: STUDY_DIRECTOR
Syneos Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Intergrated Medical and Behavioral Associates
Glendale, California, United States
Excell Research
Oceanside, California, United States
University of California, San Diego
San Diego, California, United States
Affiliated Research Institute
San Diego, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
Uptown Research Institute
Chicago, Illinois, United States
Alexian Brothers Behavioral Health
Hoffman Estates, Illinois, United States
CBH Health, LLC
Rockville, Maryland, United States
CRI Worldwide
Willingboro, New Jersey, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States
FutureSearch Clinical Trials, L.P.
Austin, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Arkhangelsk, , Russia
Kazan', , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Stavropol, , Russia
Clinical Site 1
Belgrade, , Serbia
Clinical Site 2
Belgrade, , Serbia
Clinical Site 3
Belgrade, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Crimea, , Ukraine
Dnipro, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Odesa, , Ukraine
Vinnytsia, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EVP-6124-009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.