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

May 2, 2016 updated by: FORUM Pharmaceuticals Inc

A Multicenter 26-Week Extension Study to Evaluate the Safety and Clinical Effects of Prolonged Exposure to Two Doses of EVP-6124, an Alpha-7 Nicotinic Acetylcholine Receptor Agonist, as an Adjunctive Pro-cognitive Treatment in Subjects With Schizophrenia 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 completed double-blind treatment on studies EVP-6124-015 and EVP-6124-016.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
830

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • C.a.b.a, Argentina
      • Mendoza, Argentina
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia
    • Victoria
      • Melbourne, Victoria, Australia
  • Belgium
      • Mechelen, Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Penticton, British Columbia, Canada
    • Ontario
      • Chatham, Ontario, Canada
      • Kingston, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Colombia
      • Bogota D.C, Colombia
      • Bogota D.C., Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia
    • Risaralda
      • Pereira, Risaralda, Colombia
  • Germany
      • Berlin, Germany
      • Dusseldorf, Germany
      • Leipzig, Germany
      • Mittweida, Germany
      • Stralsund, Germany
  • Italy
      • Milano, Italy
    • CT
      • Catania, CT, Italy
    • RM
      • Roma, RM, Italy
  • Mexico
      • Mexico, D.F, Mexico
      • San Luis Potosi, Mexico
    • DF
      • Mexico, DF, Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
  • Poland
      • Belchatow, Poland
  • Romania
    • Arges
      • Campulung, Arges, Romania
    • Bihor
      • Oradea, Bihor, Romania
    • Cluj
      • Cluj-Napacu, Cluj, Romania
      • Cluj-Napoca, Cluj, Romania
    • Constanta
      • Palazu-Mare, Constanta, Romania
    • Mures
      • Targu Mures, Mures, Romania
    • Sector 4
      • Bucuresti, Sector 4, Romania
  • Russian Federation
      • Moscow, Russian Federation
      • Saint Petersburg, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Stavropol, Russian Federation
      • Yaroslavl, Russian Federation
    • Arkhangelsk region
      • Talagi, Arkhangelsk region, Russian Federation
    • Smolensk Region
      • Smolensk, Smolensk Region, Russian Federation
  • Singapore
      • Singapore, Singapore
  • Spain
      • Madrid, Spain
    • Castilla y Leon
      • Salamanca, Castilla y Leon, Spain
      • Zamora, Castilla y Leon, Spain
    • Madrid
      • Alcorcon, Madrid, Spain
      • Coslada, Madrid, Spain
  • Ukraine
      • Dnipropetrovsk, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Poltara, Ukraine
      • Poltava, Ukraine
      • Vinnytsia, Ukraine
    • Kherson
      • Vil. Stepanivka, Kherson, Ukraine
  • United Kingdom
      • London, United Kingdom
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Bellflower, California, United States
      • Cerritos, California, United States
      • Chino, California, United States
      • Costa Mesa, California, United States
      • Culver City, California, United States
      • Downey, California, United States
      • Escondido, California, United States
      • Garden Grove, California, United States
      • Glendale, California, United States
      • Los Angeles, California, United States
      • Mesa, California, United States
      • Norwalk, California, United States
      • Oakland, California, United States
      • Oceanside, California, United States
      • Orange, California, United States
      • Riverside, California, United States
      • San Diego, California, United States
      • San Gabriel, California, United States
      • Santa Ana, California, United States
      • Sherman Oaks, California, United States
      • Torrance, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Lauderhill, Florida, United States
      • Miami, Florida, United States
      • Miami Springs, Florida, United States
      • North Miami, Florida, United States
      • Oakland Park, Florida, United States
      • Orange City, Florida, United States
      • Orlando, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Marietta, Georgia, United States
      • Smyrna, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Oak Brook, Illinois, United States
      • Oak Park, Illinois, United States
    • Kansas
      • Wichita, Kansas, United States
    • Louisiana
      • Lake Charles, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Mississippi
      • Flowood, Mississippi, United States
    • Missouri
      • Creve Coeur, Missouri, United States
      • O'Fallon, Missouri, United States
      • St. Charles, Missouri, United States
      • St. Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
    • New Hampshire
      • Nashua, New Hampshire, United States
    • New Jersey
      • Princeton, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Cedarhurst, New York, United States
      • Jamaica, New York, United States
      • New York, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Shaker Hts., Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Conshohocken, Pennsylvania, United States
      • Jenkintown, Pennsylvania, United States
      • Norristown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Phoenixville, Pennsylvania, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Washington
      • Bellevue, Washington, United States
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completion of the Day 182 visit in a previous 26-week double-blind study (EVP-6124-015 or EVP-6124-016).
  • Subject has signed informed consent for this extension study, indicating that the subject understands the purpose of and procedures required for the study, before the initiation of any extension study specific procedures. Subjects who are unable to provide informed consent will not be included in the study
  • No clinically significant changes in the subject's medical status during the participation in EVP-6124-015 or EVP-6124-016. Any significant changes in health care status and their impact on subject eligibility will be reviewed by the investigator and sponsor on a case-by-case basis.
  • In the opinion of the investigator, the extension treatment is in the best interest of the subject.
  • Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Females and the female partners of male must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1 year, willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least one barrier method]). Female subjects must have a negative urine pregnancy test predose on Day 1.

Exclusion Criteria:

  • Significant risk for suicidal or violent behavior, as determined by the investigator. Significant risk for suicidal behavior is defined as 1) suicidal ideation as endorsed on items 4 and 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS); 2) suicidal behaviors detected by the C-SSRS; or 3) psychiatric interview and examination.
  • Adverse events from the previous study (EVP-6124-015 or EVP-6124-016) that have not resolved, are of moderate or greater severity and judged to be possibly related or related to study drug and are thought by the investigator to be contraindications to study participation.
  • Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
  • Female subjects who are pregnant.
  • Subjects who received any other investigational treatment during participation in either EVP-6124-015 or EVP-6124-016 other than assigned study medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EVP-6124 low dose
low dose Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124
Arm 1, 2
Experimental: EVP-6124, high dose
high dose Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124
Arm 1, 2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia
Time Frame: Baseline through Day 182 or Early Termination
All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood/chemistry/urinalysis)
Baseline through Day 182 or Early Termination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in the Clinical Global Impression (CGI) - Severity (CGI-S) to Day 182
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Change from Baseline in the Clinical Global Impression (CGI) - Change (CGI-C) to Day 182
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Change from Baseline in the EuroQol-5D (EQ-5D-5L) to Day 182
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) to Day 182
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Change from Baseline in the Client Socio-Demographic and Service Receipt Inventory-European Version (CSSRI-EU) to Day 182
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FORUM Pharmaceuticals Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Syneos Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EVP-6124-017
  • 2012-003228-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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