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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

Information source: FORUM Pharmaceuticals Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Impaired Cognition

Intervention: EVP-6124 (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: FORUM Pharmaceuticals Inc

Overall contact:
Stacy Fife, Phone: 512-306-4278, Email: SM_EVP-6124-CIAS_ctgov@INCResearch.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia

Secondary outcome:

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

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

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Stacy Fife, Phone: 512-306-4278, Email: SM_EVP-6124-CIAS_ctgov@INCResearch.com

C.a.b.a, Argentina; Recruiting

Mendoza, Argentina; Recruiting

Mechelen, Belgium; Recruiting

Bogota D.C., Colombia; Recruiting

Bogota D.C, Colombia; Recruiting

Berlin, Germany; Recruiting

Dusseldorf, Germany; Recruiting

Leipzig, Germany; Recruiting

Mittweida, Germany; Recruiting

Stralsund, Germany; Recruiting

Milano, Italy; Recruiting

Mexico, D.F, Mexico; Recruiting

San Luis Potosi, Mexico; Recruiting

Belchatow, Poland; Recruiting

Moscow, Russian Federation; Recruiting

Saint Petersburg, Russian Federation; Recruiting

Saint-Petersburg, Russian Federation; Recruiting

Stavropol, Russian Federation; Recruiting

Yaroslavl, Russian Federation; Recruiting

Singapore, Singapore; Recruiting

Madrid, Spain; Recruiting

Dnipropetrovsk, Ukraine; Recruiting

Ivano-Frankivsk, Ukraine; Recruiting

Kharkiv, Ukraine; Recruiting

Kyiv, Ukraine; Recruiting

Lviv, Ukraine; Recruiting

Poltara, Ukraine; Recruiting

Poltava, Ukraine; Recruiting

Vinnytsia, Ukraine; Recruiting

London, United Kingdom; Recruiting

Calgary, Alberta, Canada; Recruiting

Medellin, Antioquia, Colombia; Recruiting

Campulung, Arges, Romania; Recruiting

Little Rock, Arkansas, United States; Recruiting

Talagi, Arkhangelsk region, Russian Federation; Recruiting

Barranquilla, Atlantico, Colombia; Recruiting

Oradea, Bihor, Romania; Recruiting

Penticton, British Columbia, Canada; Recruiting

La Plata, Buenos Aires, Argentina; Recruiting

Catania, CT, Italy; Recruiting

Anaheim, California, United States; Recruiting

Bellflower, California, United States; Recruiting

Cerritos, California, United States; Recruiting

Chino, California, United States; Terminated

Chino, California, United States; Recruiting

Costa Mesa, California, United States; Recruiting

Culver City, California, United States; Recruiting

Downey, California, United States; Recruiting

Escondido, California, United States; Recruiting

Garden Grove, California, United States; Recruiting

Glendale, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Mesa, California, United States; Recruiting

Norwalk, California, United States; Recruiting

Oakland, California, United States; Recruiting

Oceanside, California, United States; Terminated

Orange, California, United States; Recruiting

Riverside, California, United States; Recruiting

San Diego, California, United States; Recruiting

San Gabriel, California, United States; Recruiting

Santa Ana, California, United States; Recruiting

Sherman Oaks, California, United States; Recruiting

Torrance, California, United States; Recruiting

Salamanca, Castilla y Leon, Spain; Recruiting

Zamora, Castilla y Leon, Spain; Recruiting

Cluj-Napacu, Cluj, Romania; Recruiting

Cluj-Napoca, Cluj, Romania; Recruiting

Palazu-Mare, Constanta, Romania; Recruiting

Mexico, DF, Mexico; Recruiting

Washington, District of Columbia, United States; Recruiting

Lauderhill, Florida, United States; Recruiting

Miami Springs, Florida, United States; Recruiting

Miami, Florida, United States; Terminated

North Miami, Florida, United States; Recruiting

Oakland Park, Florida, United States; Recruiting

Orange City, Florida, United States; Recruiting

Orlando, Florida, United States; Recruiting

Atlanta, Georgia, United States; Recruiting

Marietta, Georgia, United States; Recruiting

Smyrna, Georgia, United States; Terminated

Chicago, Illinois, United States; Recruiting

Oak Brook, Illinois, United States; Recruiting

Oak Park, Illinois, United States; Terminated

Guadalajara, Jalisco, Mexico; Recruiting

Wichita, Kansas, United States; Recruiting

Vil. Stepanivka, Kherson, Ukraine; Recruiting

Lake Charles, Louisiana, United States; Recruiting

Shreveport, Louisiana, United States; Recruiting

Alcorcon, Madrid, Spain; Recruiting

Coslada, Madrid, Spain; Recruiting

Boston, Massachusetts, United States; Recruiting

Minneapolis, Minnesota, United States; Terminated

Flowood, Mississippi, United States; Recruiting

Creve Coeur, Missouri, United States; Recruiting

O'Fallon, Missouri, United States; Recruiting

St. Charles, Missouri, United States; Recruiting

St. Louis, Missouri, United States; Recruiting

Targu Mures, Mures, Romania; Recruiting

Lincoln, Nebraska, United States; Terminated

Omaha, Nebraska, United States; Recruiting

Nashua, New Hampshire, United States; Recruiting

Princeton, New Jersey, United States; Recruiting

Albuquerque, New Mexico, United States; Recruiting

Cedarhurst, New York, United States; Recruiting

Jamaica, New York, United States; Recruiting

New York, New York, United States; Recruiting

Charlotte, North Carolina, United States; Recruiting

Monterrey, Nuevo Leon, Mexico; Recruiting

Cleveland, Ohio, United States; Recruiting

Shaker Hts., Ohio, United States; Recruiting

Oklahoma City, Oklahoma, United States; Recruiting

Chatham, Ontario, Canada; Recruiting

Kingston, Ontario, Canada; Recruiting

Conshohocken, Pennsylvania, United States; Recruiting

Jenkintown, Pennsylvania, United States; Recruiting

Norristown, Pennsylvania, United States; Recruiting

Philadelphia, Pennsylvania, United States; Recruiting

Phoenixville, Pennsylvania, United States; Recruiting

Montreal, Quebec, Canada; Recruiting

Roma, RM, Italy; Recruiting

Pereira, Risaralda, Colombia; Recruiting

Bucuresti, Sector 4, Romania; Recruiting

Smolensk, Smolensk Region, Russian Federation; Recruiting

Adelaide, South Australia, Australia; Recruiting

Austin, Texas, United States; Recruiting

Dallas, Texas, United States; Recruiting

Salt Lake City, Utah, United States; Recruiting

Melbourne, Victoria, Australia; Recruiting

Bellevue, Washington, United States; Recruiting

Spokane, Washington, United States; Recruiting

Additional Information

Starting date: June 2013
Last updated: June 23, 2015

Page last updated: August 23, 2015

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