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



Status:Completed
Conditions:Cognitive Studies, Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 50
Updated:5/4/2016
Start Date:June 2013
End Date:October 2015

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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.


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.
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