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 | Completed Phase 3

• 2 other identifiers: EVP-6124-0172012-003228-19
• Study Type: interventional
• Target: 830
• Locations: 16 countries
• Sites: 128

Brief 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.

Conditions

Schizophrenia; Impaired Cognition

Keywords

Schizophrenia; Cognition; Cognition Impairment; Alpha-7 nAChR

Outcome Measures

Primary Outcomes (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)

  Baseline through Day 182 or Early Termination

Secondary Outcomes (5)

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

  Baseline to Day 182 or Early Termination

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

  Baseline to Day 182 or Early Termination

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

  Baseline to Day 182 or Early Termination

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

  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

  Baseline to Day 182 or Early Termination

Study Arms (2)

EVP-6124 low dose

EXPERIMENTAL

low dose Tablet, Once Daily, Day 1 through Day 182

Drug: EVP-6124

EVP-6124, high dose

EXPERIMENTAL

high dose Tablet, Once Daily, Day 1 through Day 182

Drug: EVP-6124

Interventions

EVP-6124 DRUG

Arm 1, 2

EVP-6124 low dose; EVP-6124, high dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FORUM Pharmaceuticals Inc: lead
• Syneos Health: collaborator

Study Sites (128)

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Bellflower, California, United States

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Cerritos, California, United States

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Chino, California, United States

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Costa Mesa, California, United States

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Culver City, California, United States

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Downey, California, United States

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Escondido, California, United States

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Garden Grove, California, United States

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Glendale, California, United States

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Los Angeles, California, United States

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Mesa, California, United States

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Norwalk, California, United States

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Oakland, California, United States

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Oceanside, California, United States

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Orange, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Gabriel, California, United States

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Santa Ana, California, United States

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Sherman Oaks, California, United States

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Torrance, California, United States

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Washington D.C., District of Columbia, United States

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Lauderhill, Florida, United States

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Miami, Florida, United States

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Miami Springs, Florida, United States

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North Miami, Florida, United States

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Oakland Park, Florida, United States

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Orange City, Florida, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Smyrna, Georgia, United States

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Chicago, Illinois, United States

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Oak Brook, Illinois, United States

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Oak Park, Illinois, United States

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Wichita, Kansas, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Flowood, Mississippi, United States

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Creve Coeur, Missouri, United States

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O'Fallon, Missouri, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Nashua, New Hampshire, United States

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Princeton, New Jersey, United States

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Albuquerque, New Mexico, United States

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Cedarhurst, New York, United States

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Jamaica, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Cleveland, Ohio, United States

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Shaker Hts., Ohio, United States

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Oklahoma City, Oklahoma, United States

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Conshohocken, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Phoenixville, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Salt Lake City, Utah, United States

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Bellevue, Washington, United States

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Spokane, Washington, United States

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La Plata, Buenos Aires, Argentina

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Mendoza, Mendoza Province, Argentina

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C.a.b.a, Argentina

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Adelaide, South Australia, Australia

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Melbourne, Victoria, Australia

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Mechelen, Belgium

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Calgary, Alberta, Canada

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Penticton, British Columbia, Canada

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Chatham, Ontario, Canada

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Kingston, Ontario, Canada

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Montreal, Quebec, Canada

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Medellín, Antioquia, Colombia

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Barranquilla, Atlántico, Colombia

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Pereira, Risaralda Department, Colombia

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Bogota D.C., Colombia

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Bogota D.C, Colombia

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Berlin, Germany

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Düsseldorf, Germany

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Leipzig, Germany

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Mittweida, Germany

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Stralsund, Germany

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Catania, CT, Italy

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Milan, Milano, Italy

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Roma, RM, Italy

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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San Luis Potosí City, San Luis Potosí, Mexico

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Mexico City, Mexico

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Bełchatów, Poland

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Campulung Muscel, Argeş, Romania

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Oradea, Bihor County, Romania

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Cluj-Napacu, Cluj, Romania

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Cluj-Napoca, Cluj, Romania

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Palazu Mare, Constanța County, Romania

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Târgu Mureş, Mureș County, Romania

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Bucharest, Sector 4, Romania

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Talagi, Arkhangelskaya oblast, Russia

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Smolensk, Smolensk Oblast, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Stavropol, Russia

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Yaroslavl, Russia

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Singapore, Singapore, Singapore

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Salamanca, Castille and León, Spain

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Zamora, Castille and León, Spain

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Alcorcón, Madrid, Spain

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Coslada, Madrid, Spain

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Madrid, Madrid, Spain

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Vil. Stepanivka, Kherson Oblast, Ukraine

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Dnipropetrovsk, Ukraine

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Ivano-Frankivsk, Ukraine

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Kharkiv, Ukraine

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Kyiv, Ukraine

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Lviv, Ukraine

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Poltara, Ukraine

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Poltava, Ukraine

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Vinnytsia, Ukraine

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London, United Kingdom

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MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Interventions

7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 26, 2012
• Study Start: June 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 3, 2016

Record last verified: 2015-09

Locations

BE (1); CA (5); UA (9); ME (5); PL (1); AU (2); IT (3); CO (5); SG (1); US (69); GB (1); RU (6); ES (5); RO (7); AR (3); DE (5)