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SchizophreniaPhase 3NCT01714713

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

A Phase 3 study testing EVP-6124 in people with Schizophrenia and Impaired Cognition, run by FORUM Pharmaceuticals Inc at 128 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Schizophrenia, Impaired Cognition
What is being tested?
EVP-6124
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
830 participants
Where
128 sitesin 16 countries
Study dates
Jun 2013to Oct 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

128 sites in 16 countries.

128 sites in 16 countries

United States69 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anaheim, California

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bellevue, Washington

  • Study site

    Bellflower, California

  • Study site

    Boston, Massachusetts

  • Study site

    Cedarhurst, New York

  • Study site

    Cerritos, California

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Chino, California

  • Study site

    Cleveland, Ohio

  • Study site

    Conshohocken, Pennsylvania

  • Study site

    Costa Mesa, California

  • Study site

    Creve Coeur, Missouri

  • Study site

    Culver City, California

  • Study site

    Dallas, Texas

  • Study site

    Downey, California

  • Study site

    Escondido, California

  • Study site

    Flowood, Mississippi

  • Study site

    Garden Grove, California

  • Study site

    Glendale, California

  • Study site

    Jamaica, New York

  • Study site

    Jenkintown, Pennsylvania

  • Study site

    Lake Charles, Louisiana

  • Study site

    Lauderhill, Florida

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Marietta, Georgia

  • Study site

    Mesa, California

  • Study site

    Miami, Florida

  • Study site

    Miami Springs, Florida

  • Study site

    Minneapolis, Minnesota

  • Study site

    Nashua, New Hampshire

  • Study site

    New York, New York

  • Study site

    Norristown, Pennsylvania

  • Study site

    North Miami, Florida

  • Study site

    Norwalk, California

  • Study site

    O'Fallon, Missouri

  • Study site

    Oak Brook, Illinois

  • Study site

    Oak Park, Illinois

  • Study site

    Oakland, California

  • Study site

    Oakland Park, Florida

  • Study site

    Oceanside, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Orange City, Florida

  • Study site

    Orlando, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenixville, Pennsylvania

  • Study site

    Princeton, New Jersey

  • Study site

    Riverside, California

  • Study site

    Saint Charles, Missouri

  • Study site

    Salt Lake City, Utah

  • Study site

    San Diego, California

  • Study site

    San Gabriel, California

  • Study site

    Santa Ana, California

  • Study site

    Shaker Hts., Ohio

  • Study site

    Sherman Oaks, California

  • Study site

    Shreveport, Louisiana

  • Study site

    Smyrna, Georgia

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Torrance, California

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wichita, Kansas

Other trials in United States

Ukraine9 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Poltara

  • Study site

    Poltava

  • Study site

    Vil. Stepanivka, Kherson Oblast

  • Study site

    Vinnytsia

Other trials in Ukraine

Romania7 sites

  • Study site

    Bucharest, Sector 4

  • Study site

    Campulung Muscel, Argeş

  • Study site

    Cluj-Napacu, Cluj

  • Study site

    Cluj-Napoca, Cluj

  • Study site

    Oradea, Bihor County

  • Study site

    Palazu Mare, Constanța County

  • Study site

    Târgu Mureş, Mureș County

Other trials in Romania

Russia6 sites

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Smolensk, Smolensk Oblast

  • Study site

    Stavropol

  • Study site

    Talagi, Arkhangelskaya oblast

  • Study site

    Yaroslavl

Other trials in Russia

Canada5 sites

  • Study site

    Calgary, Alberta

  • Study site

    Chatham, Ontario

  • Study site

    Kingston, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Penticton, British Columbia

Other trials in Canada

Colombia5 sites

  • Study site

    Barranquilla, Atlántico

  • Study site

    Bogota D.C

  • Study site

    Bogota D.C.

  • Study site

    Medellín, Antioquia

  • Study site

    Pereira, Risaralda Department

Other trials in Colombia

Germany5 sites

  • Study site

    Berlin

  • Study site

    Düsseldorf

  • Study site

    Leipzig

  • Study site

    Mittweida

  • Study site

    Stralsund

Other trials in Germany

Mexico5 sites

  • Study site

    Guadalajara, Jalisco

  • Study site

    Mexico City, Mexico City

  • Study site

    Mexico City

  • Study site

    Monterrey, Nuevo León

  • Study site

    San Luis Potosí City, San Luis Potosí

Other trials in Mexico

Spain5 sites

  • Study site

    Alcorcón, Madrid

  • Study site

    Coslada, Madrid

  • Study site

    Madrid, Madrid

  • Study site

    Salamanca, Castille and León

  • Study site

    Zamora, Castille and León

Other trials in Spain

Argentina3 sites

  • Study site

    C.a.b.a

  • Study site

    La Plata, Buenos Aires

  • Study site

    Mendoza, Mendoza Province

Other trials in Argentina

Italy3 sites

  • Study site

    Catania, CT

  • Study site

    Milan, Milano

  • Study site

    Roma, RM

Other trials in Italy

Australia2 sites

  • Study site

    Adelaide, South Australia

  • Study site

    Melbourne, Victoria

Other trials in Australia

Belgium1 site

  • Study site

    Mechelen

Other trials in Belgium

Poland1 site

  • Study site

    Bełchatów

Other trials in Poland

Singapore1 site

  • Study site

    Singapore, Singapore

Other trials in Singapore

United Kingdom1 site

  • Study site

    London

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
EVP-6124
Keywords
Schizophrenia, Cognition, Cognition Impairment, Alpha-7 nAChR
Medical subject headings
Schizophrenia, Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EVP-6124Drug

    Arm 1, 2

Study groups in NCT01714713
Study groupRoleWhat they receive
EVP-6124 low doseExperimentallow dose Tablet, Once Daily, Day 1 through Day 182
Receives: Drug: EVP-6124
EVP-6124, high doseExperimentalhigh dose Tablet, Once Daily, Day 1 through Day 182
Receives: Drug: EVP-6124

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia

    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)

    Measured: Baseline through Day 182 or Early Termination

Secondary outcomes (5)

  1. Change from Baseline in the Clinical Global Impression (CGI) - Severity (CGI-S) to Day 182

    Measured: Baseline to Day 182 or Early Termination

  2. Change from Baseline in the Clinical Global Impression (CGI) - Change (CGI-C) to Day 182

    Measured: Baseline to Day 182 or Early Termination

  3. Change from Baseline in the EuroQol-5D (EQ-5D-5L) to Day 182

    Measured: Baseline to Day 182 or Early Termination

  4. Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) to Day 182

    Measured: Baseline to Day 182 or Early Termination

  5. Change from Baseline in the Client Socio-Demographic and Service Receipt Inventory-European Version (CSSRI-EU) to Day 182

    Measured: Baseline to Day 182 or Early Termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2012 (estimated)
  2. Study startJun 2013
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
830 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01714713
Sponsor's protocol ID
EVP-6124-017
Other IDs
2012-003228-19
Status last verified
Sep 2015
First submitted
19 Oct 2012
Last updated
3 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EVP-6124 in people with Schizophrenia and Impaired Cognition, run by FORUM Pharmaceuticals Inc at 128 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States, Ukraine, Romania, Russia, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia (time frame: Baseline through Day 182 or Early Termination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01714713.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.

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