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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); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: FORUM Pharmaceuticals Inc


The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic therapy.

Clinical Details

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel, 26-Week, Phase 3 Study of 2 Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo as an Adjunctive Pro-cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy

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

Primary outcome:

Change from Baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) to Day 182

Change from Baseline in the Schizophrenia Cognition Rating Scale (SCoRs) to Day 182

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

Secondary outcome:

Change from Baseline in the Positive and Negative Symptom Scale (PANSS) to Day 182

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

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

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


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


Inclusion Criteria:

- Age 18 to 50 years of age, inclusive

- Signed informed consent, indicating that the subject understands the purpose of and

procedures required for the study, before the initiation of any study specific procedures. Subjects who are unable to provide informed consent will not be included in the study.

- Resides in a stable living situation, according to the investigator's judgment, and

must have an identified informant who should be consistent throughout the study. If possible, the informant should accompany the subject or be available for in person ratings at the screening, baseline (Day 1), and final study visits. In person informant ratings on all relevant study visits are preferred whenever possible. However, if the informant is not available for in person ratings, telephone interview is acceptable. The informant must be available for a telephone interview throughout the study at all visits. As long as both the informant visit and subject visit are within the study visit windows, it is not necessary that they occur on the same day. The informant must interact with the subject at least 2 times a week.

- Diagnosis of Schizophrenia of at least 3 years duration. This diagnosis can be

established utilizing the SCID-I, direct clinical assessments, family, informants, and confirmation of diagnosis from clinical sources. These may include medical records, confirmation of diagnosis by treating clinician through telephone contact, or written confirmation from treating clinic. If the listed sources are not available, other sources of diagnostic confirmation may also be acceptable after discussion with the medical monitor.

- Treated with atypical antipsychotic drug (in any approved dosage form) other than

Clozapine at a stable dose for at least 8 weeks prior to screening and be clinically stable; the subject must remain clinically stable (in the opinion of the principal investigator) through randomization. The use of up to 2 atypical antipsychotic drugs is permitted, as long as in the opinion of the investigator, the second medication is not required to control treatment-resistant or intractable psychotic symptoms. No subject will be washed off antipsychotic therapy to become eligible for this study.

- Schizophrenia clinical symptom burden severity defined by the following: a Brief

Psychiatric Rating Scale (BPRS) Conceptual Disorganization item score ≤ 4; and a BPRS Hallucinatory Behavior item score ≤ 5, or an Unusual Thought Content item score ≤ 5. Either Hallucinatory Behavior or Unusual Thought Content, but not both, may have a score of 6 (but not > 6).

- Simpson-Angus Scale (SAS) total score ≤ 6

- Calgary Depression Scale for Schizophrenia (CDSS) total score ≤ 10

- General health status acceptable for participation in a 26-week clinical study

- Fertile, sexually active subjects (men and women) must use an effective method of

contraception during the study

- Fluency (oral and written) in the language in which the standardized tests will be


- The ability to refrain from using any tobacco or other nicotine-containing products

for at least 30 minutes before any cognitive testing Exclusion Criteria:

- Hospitalization within 12 weeks before screening or during the screening period, or

change of antipsychotic medication or dose within 8 weeks before screening or during the screening period.

- Participation in another therapeutic (medication administration) clinical study

within the past 2 months.

- Psychiatric hospitalization or incarcerations due to breakthrough symptoms or acute

exacerbations for a period of 3 months before screening. Subjects with a recent "social" hospitalization or incarceration may be entered into screening after consultation with the medical monitor

- Likelihood, in the opinion of the investigator, that either the subject or informant

will be unable to complete a 26-week study

- Treatment with prohibited antipsychotic drug, and/or treatment with more than 2

permitted antipsychotic drugs. Treatment with a first-generation antipsychotic drug (typical antipsychotic) is prohibited unless it is administered at a low dose after discussion with the medical monitor

- Current treatment with any anticholinergic agent

- Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)

criteria met for alcohol abuse within the past 3 months or substance abuse (other than nicotine) within the last 6 months before screening

- Significant suicide risk as defined by 1) suicidal ideation as endorsed on items 4 or

5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past year; 2) suicidal behavior detected by the C-SSRS during the past 2 years, or 3) psychiatric interview and examination

- Stroke within 6 months before screening, history of brain tumor, subdural hematoma,

or other clinically significant neurological condition, head trauma with loss of consciousness within 12 months before screening

- Monoamine oxidase inhibitor antidepressants or tricyclic medications used in

antidepressant doses are excluded. Other antidepressant medications are allowed if the subject has been treated with a stable dose for at least 3 months before screening

- Immunosuppressants, mood stabilizers, chronic use of a sedative hypnotic drug,

chronic intake of clinically significant doses of opioid containing analgesics or any current methadone treatment all in the judgment of the investigator may be permitted depending on the circumstance

- Use of Central Nervous System(CNS) stimulants

- Nicotine therapy (including patches), varenicline (Chantix), or similar therapeutic

agent within the last six months before screening

- Use of a benzodiazepine medication is allowed if the subject has not had a change in

medication or dose for at least 3 months. For subjects prescribed benzodiazepines, short-acting benzodiazepines are to be used whenever possible. Use of longer-acting benzodiazepines may be acceptable if prior authorization is obtained from the medical monitor. When possible, benzodiazepines should not be administered within 3 hours before cognitive testing. The use of more than one sedative-hypnotic medication is not allowed.

Locations and Contacts

Caba, Argentina

Mendoza, Argentina

Santiago del Estero, Argentina

Bogota D.C., Colombia

Ban, Italy

Barl, Italy

Catania, Italy

Lucca, Italy

Milano, Italy

Pisa, Italy

Roma, Italy

Mexico, D.F, Mexico

San Luis Potosi, Mexico

Belchatow, Poland

Chelmno, Poland

Karakow, Poland

Kielce, Poland

Kotarbinskiego, Poland

Sosnowiec, Poland

Torun, Poland

Wroclaw, Poland

Iasi, Romania

Moscow, Russian Federation

Saint-Petersburg, Russian Federation

Samara, Russian Federation

Yaroslavl, Russian Federation

Dnipropetrovsk, Ukraine

Kharkiv, Ukraine

Kyiv, Ukraine

Lviv, Ukraine

Poltava, Ukraine

Vinnytsia, Ukraine

Exeter, United Kingdom

London, United Kingdom

Medellin, Antioquia, Colombia

Campulung, Arges, Romania

Phoenixville, Arizona, United States

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Barranquilla, Atlantico, Colombia

Salvader, BA, Brazil

Oradea, Bihor, Romania

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Sherman Oaks, California, United States

Cambridge, Cambridgeshire, United Kingdom

Cluj-Napoca, Cluj, Romania

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Washington, District of Columbia, United States

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Wichita, Kansas, United States

vil. Stepanivka, Kherson, Ukraine

Saint-Petersburg, Leningrad, Russian Federation

Lake Charles, Louisiana, United States

Shreveport, Louisiana, United States

Belo Horizonte, MG, Brazil

Milan, MI, Italy

Rockville, Maryland, United States

Boston, Massachusetts, United States

St. Charles, Missouri, United States

St. Louis, Missouri, United States

Targu-Mures, Munes, Romania

Lincoln, Nebraska, United States

Princeton, New Jersey, United States

Jamaica, New York, United States

New York, New York, United States

Rochester, New York, United States

Charlotte, North Carolina, United States

Monterrey, Nuevo Leon, Mexico

Beachwood, Ohio, United States

Oklahoma City, Oklahoma, United States

Curitiba, Parana, Brazil

Jenkintown, Pennsylvania, United States

Pereira, Risaralda, Colombia

Rosario, Santa Fe, Argentina

Bucuresti, Sector 4, Romania

Smolensk, Smolensk region, Russian Federation

Adelaide, South Australia, Australia

Austin, Texas, United States

Dallas, Texas, United States

Newcastle-upon-Tyne, Tyne and Wear, United Kingdom

Salt Lake City, Utah, United States

Bellevue, Washington, United States

Richland, Washington, United States

Spokane, Washington, United States

Mt. Claremont, Western Australia, Australia

Additional Information

Starting date: October 2012
Last updated: June 23, 2015

Page last updated: August 23, 2015

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