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
Verified September 2014 by FORUM Pharmaceuticals Inc
Information provided by (Responsible Party):
FORUM Pharmaceuticals Inc
First received: October 19, 2012
Last updated: September 25, 2014
Last verified: September 2014
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.
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia [ Time Frame: Baseline through Day 182 or Early Termination ] [ Designated as safety issue: Yes ]
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:
- Change from Baseline in the Clinical Global Impression (CGI) - Severity (CGI-S) to Day 182 [ Time Frame: Baseline to Day 182 or Early Termination ] [ Designated as safety issue: No ]
- Change from Baseline in the Clinical Global Impression (CGI) - Change (CGI-C) to Day 182 [ Time Frame: Baseline to Day 182 or Early Termination ] [ Designated as safety issue: No ]
- Change from Baseline in the EuroQol-5D (EQ-5D-5L) to Day 182 [ Time Frame: Baseline to Day 182 or Early Termination ] [ Designated as safety issue: No ]
- Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) to Day 182 [ Time Frame: Baseline to Day 182 or Early Termination ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||September 2016 (Final data collection date for primary outcome measure)
Experimental: EVP-6124 low dose
low dose Tablet, Once Daily, Day 1 through Day 182
Arm 1, 2
Experimental: EVP-6124, high dose
high dose Tablet, Once Daily, Day 1 through Day 182
Arm 1, 2
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01714713
FORUM Pharmaceuticals Inc
No publications provided
||FORUM Pharmaceuticals Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 19, 2012
||September 25, 2014
||United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Argentina: Ministry of Health
Australia: National Health and Medical Research Council
Canada: Health Canada
Colombia: National Institutes of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Mexico: Ministry of Health
Romania: National Agency for Medicines and Medical Devices
Russia: Pharmacological Committee, Ministry of Health
Singapore: Singapore Clinical Research Institute
Spain: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ukraine: State Pharmacological Center - Ministry of Health
Brazil: Ministry of Health
Poland: Ministry of Health
Serbia: Medicines and Medical Devices Agency
Keywords provided by FORUM Pharmaceuticals Inc:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2014
Schizophrenia and Disorders with Psychotic Features
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action