Clinical trial NCT01714713: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Impaired Cognition
Keywords: Schizophrenia
Cognition
Cognition Impairment
Alpha-7 nAChR
Lead sponsor: FORUM Pharmaceuticals Inc
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2012-10-26
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia
timeFrame: Baseline through Day 182 or Early Termination
Secondary outcomes:
measure: Change from Baseline in the Clinical Global Impression (CGI) - Severity (CGI-S) to Day 182
timeFrame: Baseline to Day 182 or Early Termination
measure: Change from Baseline in the Clinical Global Impression (CGI) - Change (CGI-C) to Day 182
timeFrame: Baseline to Day 182 or Early Termination
measure: Change from Baseline in the EuroQol-5D (EQ-5D-5L) to Day 182
timeFrame: Baseline to Day 182 or Early Termination
measure: Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) to Day 182
timeFrame: Baseline to Day 182 or Early Termination
measure: Change from Baseline in the Client Socio-Demographic and Service Receipt Inventory-European Version (CSSRI-EU) to Day 182
timeFrame: Baseline to Day 182 or Early Termination
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
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state: California
city: Bellflower
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state: California
city: Cerritos
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state: California
city: Chino
country: United States
state: California
city: Costa Mesa
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state: California
city: Culver City
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state: California
city: Downey
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state: California
city: Escondido
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state: California
city: Garden Grove
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state: California
city: Glendale
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state: California
city: Los Angeles
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state: California
city: Mesa
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state: California
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city: Oakland
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state: California
city: Oceanside
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state: California
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state: California
city: San Gabriel
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city: Santa Ana
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state: California
city: Sherman Oaks
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state: California
city: Torrance
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state: California
city: Washington
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state: District of Columbia
city: Lauderhill
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state: Florida
city: Miami Springs
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state: Florida
city: Miami
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state: Florida
city: North Miami
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state: Florida
city: Oakland Park
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state: Florida
city: Orange City
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state: Florida
city: Orlando
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state: Florida
city: Atlanta
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state: Georgia
city: Marietta
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state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Chicago
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state: Illinois
city: Oak Brook
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state: Illinois
city: Oak Park
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state: Illinois
city: Wichita
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state: Kansas
city: Lake Charles
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state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Boston
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state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Flowood
country: United States
state: Mississippi
city: Creve Coeur
country: United States
state: Missouri
city: O'Fallon
country: United States
state: Missouri
city: St. Charles
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Lincoln
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state: Nebraska
city: Omaha
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state: Nebraska
city: Nashua
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state: New Hampshire
city: Princeton
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Cedarhurst
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Shaker Hts.
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Conshohocken
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Phoenixville
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Bellevue
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: La Plata
country: Argentina
state: Buenos Aires
city: C.a.b.a
country: Argentina
city: Mendoza
country: Argentina
city: Adelaide
country: Australia
state: South Australia
city: Melbourne
country: Australia
state: Victoria
city: Mechelen
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Penticton
country: Canada
state: British Columbia
city: Chatham
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Medellin
country: Colombia
state: Antioquia
city: Barranquilla
country: Colombia
state: Atlantico
city: Pereira
country: Colombia
state: Risaralda
city: Bogota D.C.
country: Colombia
city: Bogota D.C
country: Colombia
city: Berlin
country: Germany
city: Dusseldorf
country: Germany
city: Leipzig
country: Germany
city: Mittweida
country: Germany
city: Stralsund
country: Germany
city: Catania
country: Italy
state: CT
city: Roma
country: Italy
state: RM
city: Milano
country: Italy
city: Mexico
country: Mexico
state: DF
city: Guadalajara
country: Mexico
state: Jalisco
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Mexico, D.F
country: Mexico
city: San Luis Potosi
country: Mexico
city: Belchatow
country: Poland
city: Campulung
country: Romania
state: Arges
city: Oradea
country: Romania
state: Bihor
city: Cluj-Napacu
country: Romania
state: Cluj
city: Cluj-Napoca
country: Romania
state: Cluj
city: Palazu-Mare
country: Romania
state: Constanta
city: Targu Mures
country: Romania
state: Mures
city: Bucuresti
country: Romania
state: Sector 4
city: Talagi
country: Russian Federation
state: Arkhangelsk region
city: Smolensk
country: Russian Federation
state: Smolensk Region
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Singapore
country: Singapore
city: Salamanca
country: Spain
state: Castilla y Leon
city: Zamora
country: Spain
state: Castilla y Leon
city: Alcorcon
country: Spain
state: Madrid
city: Coslada
country: Spain
state: Madrid
city: Madrid
country: Spain
city: Vil. Stepanivka
country: Ukraine
state: Kherson
city: Dnipropetrovsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Poltara
country: Ukraine
city: Poltava
country: Ukraine
city: Vinnytsia
country: Ukraine
city: London
country: United Kingdom
Study officials:
References: