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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01714713




Registration number
NCT01714713
Ethics application status
Date submitted
19/10/2012
Date registered
26/10/2012
Date last updated
3/05/2016

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2012-003228-19
Secondary ID [2] 0 0
EVP-6124-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Impaired Cognition 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EVP-6124

Experimental: EVP-6124 low dose - low dose Tablet, Once Daily, Day 1 through Day 182

Experimental: EVP-6124, high dose - high dose Tablet, Once Daily, Day 1 through Day 182


Treatment: Drugs: EVP-6124
Arm 1, 2
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia
Timepoint [1] 0 0
Baseline through Day 182 or Early Termination
Secondary outcome [1] 0 0
Change from Baseline in the Clinical Global Impression (CGI) - Severity (CGI-S) to Day 182
Timepoint [1] 0 0
Baseline to Day 182 or Early Termination
Secondary outcome [2] 0 0
Change from Baseline in the Clinical Global Impression (CGI) - Change (CGI-C) to Day 182
Timepoint [2] 0 0
Baseline to Day 182 or Early Termination
Secondary outcome [3] 0 0
Change from Baseline in the EuroQol-5D (EQ-5D-5L) to Day 182
Timepoint [3] 0 0
Baseline to Day 182 or Early Termination
Secondary outcome [4] 0 0
Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) to Day 182
Timepoint [4] 0 0
Baseline to Day 182 or Early Termination
Secondary outcome [5] 0 0
Change from Baseline in the Client Socio-Demographic and Service Receipt Inventory-European Version (CSSRI-EU) to Day 182
Timepoint [5] 0 0
Baseline to Day 182 or Early Termination

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
830
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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United States of America
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District of Columbia
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Florida
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Georgia
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Illinois
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Kansas
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Louisiana
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Massachusetts
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Minnesota
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Mississippi
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Missouri
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Nebraska
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Utah
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Washington
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Argentina
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Buenos Aires
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Argentina
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C.a.b.a
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Mendoza
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Belgium
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Mechelen
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Risaralda
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Bogota D.C.
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Colombia
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Germany
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Berlin
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Germany
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Germany
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Leipzig
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Germany
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Mittweida
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Germany
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Stralsund
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CT
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Poland
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Arges
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Romania
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Bihor
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Romania
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Cluj
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Romania
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Constanta
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Romania
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Mures
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Romania
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Sector 4
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Russian Federation
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Arkhangelsk region
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Russian Federation
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Smolensk Region
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Stavropol
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Russian Federation
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Yaroslavl
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Singapore
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Singapore
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Spain
State/province [66] 0 0
Castilla y Leon
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Spain
State/province [67] 0 0
Madrid
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Ukraine
State/province [68] 0 0
Kherson
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Ukraine
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Dnipropetrovsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Poltara
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Ukraine
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Poltava
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Ukraine
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Vinnytsia
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United Kingdom
State/province [77] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
FORUM Pharmaceuticals Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01714713
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01714713