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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714713
• Other study ID #: EVP-6124-017
• Secondary ID: 2012-003228-19
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2012
• Last updated: May 2, 2016
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: September 2015
• Source: FORUM Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesArgentina: Ministry of HealthAustralia: National Health and Medical Research CouncilCanada: Health CanadaColombia: National Institutes of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthMexico: Ministry of HealthRomania: National Agency for Medicines and Medical DevicesRussia: Pharmacological Committee, Ministry of HealthSingapore: Singapore Clinical Research InstituteSpain: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUkraine: State Pharmacological Center - Ministry of HealthBrazil: Ministry of HealthPoland: Ministry of HealthSerbia: Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 830
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Impaired Cognition
• Schizophrenia

Intervention

Drug:
• EVP-6124
Arm 1, 2

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
FORUM Pharmaceuticals Inc	INC Research

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Colombia,  Germany,  Italy,  Mexico,  Poland,  Romania,  Russian Federation,  Singapore,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia	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)	Baseline through Day 182 or Early Termination	Yes
Secondary	Change from Baseline in the Clinical Global Impression (CGI) - Severity (CGI-S) to Day 182		Baseline to Day 182 or Early Termination	No
Secondary	Change from Baseline in the Clinical Global Impression (CGI) - Change (CGI-C) to Day 182		Baseline to Day 182 or Early Termination	No
Secondary	Change from Baseline in the EuroQol-5D (EQ-5D-5L) to Day 182		Baseline to Day 182 or Early Termination	No
Secondary	Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) to Day 182		Baseline to Day 182 or Early Termination	No
Secondary	Change from Baseline in the Client Socio-Demographic and Service Receipt Inventory-European Version (CSSRI-EU) to Day 182		Baseline to Day 182 or Early Termination	No