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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

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ClinicalTrials.gov Identifier: NCT01714713
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : May 3, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Impaired Cognition Drug: EVP-6124 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2013
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: EVP-6124 low dose
low dose Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124
Arm 1, 2
Experimental: EVP-6124, high dose
high dose Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124
Arm 1, 2

Outcome Measures

Primary Outcome Measures :
  1. Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia [ Time Frame: Baseline through Day 182 or Early Termination ]
    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)

Secondary Outcome Measures :
  1. Change from Baseline in the Clinical Global Impression (CGI) - Severity (CGI-S) to Day 182 [ Time Frame: Baseline to Day 182 or Early Termination ]
  2. Change from Baseline in the Clinical Global Impression (CGI) - Change (CGI-C) to Day 182 [ Time Frame: Baseline to Day 182 or Early Termination ]
  3. Change from Baseline in the EuroQol-5D (EQ-5D-5L) to Day 182 [ Time Frame: Baseline to Day 182 or Early Termination ]
  4. Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) to Day 182 [ Time Frame: Baseline to Day 182 or Early Termination ]
  5. Change from Baseline in the Client Socio-Demographic and Service Receipt Inventory-European Version (CSSRI-EU) to Day 182 [ Time Frame: Baseline to Day 182 or Early Termination ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714713

  Show 129 Study Locations
Sponsors and Collaborators
FORUM Pharmaceuticals Inc
INC Research
More Information

Responsible Party: FORUM Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT01714713     History of Changes
Other Study ID Numbers: EVP-6124-017
2012-003228-19 ( EudraCT Number )
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: September 2015

Keywords provided by FORUM Pharmaceuticals Inc:
Cognition Impairment
Alpha-7 nAChR

Additional relevant MeSH terms:
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Antipsychotic Agents
Nicotinic Agonists
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action