Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01714661




Registration number
NCT01714661
Ethics application status
Date submitted
19/10/2012
Date registered
26/10/2012
Date last updated
3/05/2016

Titles & IDs
Public title
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 Randomized, Double-blind, Placebo-controlled, Parallel, 26-Week, Phase 3 Study of 2 Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo as an Adjunctive Pro-cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy
Secondary ID [1] 0 0
2012-003208-10
Secondary ID [2] 0 0
EVP-6124-015
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
Treatment: Drugs - Placebo

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

Placebo comparator: EVP-6124, Placebo - Placebo, Tablet, Once Daily, Day -14 through Day 182


Treatment: Drugs: EVP-6124
Arms 1, 2

Treatment: Drugs: Placebo
Arm 3
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) to Day 182
Timepoint [1] 0 0
Baseline to Day 182 or Early Termination
Primary outcome [2] 0 0
Change from Baseline in the Schizophrenia Cognition Rating Scale (SCoRs) to Day 182
Timepoint [2] 0 0
Baseline to Day 182 or Early Terminiation
Primary outcome [3] 0 0
Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia
Timepoint [3] 0 0
Screening (Day -42 to Day -15) to Day 182 or Early Terminiation
Secondary outcome [1] 0 0
Change from Baseline in the Positive and Negative Symptom Scale (PANSS) 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-Severity (CGI-S) to Day 182
Timepoint [2] 0 0
Baseline to Day 182 or Early Termination
Secondary outcome [3] 0 0
Change from Baseline in the Clinical Global Impression Change Scale (CGI-C) to Day 182
Timepoint [3] 0 0
Baseline to Day 182 or Early Termination
Secondary outcome [4] 0 0
Change from Baseline in the EuroQOL-5D (EQ-5D) to Day 182
Timepoint [4] 0 0
Baseline to Day 182 or Early Termination

Eligibility
Key inclusion criteria
* Age 18 to 50 years of age, inclusive
* Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study, before the initiation of any study specific procedures. Subjects who are unable to provide informed consent will not be included in the study.
* Resides in a stable living situation, according to the investigator's judgment, and must have an identified informant who should be consistent throughout the study. If possible, the informant should accompany the subject or be available for in person ratings at the screening, baseline (Day 1), and final study visits. In person informant ratings on all relevant study visits are preferred whenever possible. However, if the informant is not available for in person ratings, telephone interview is acceptable. The informant must be available for a telephone interview throughout the study at all visits. As long as both the informant visit and subject visit are within the study visit windows, it is not necessary that they occur on the same day. The informant must interact with the subject at least 2 times a week.
* Diagnosis of Schizophrenia of at least 3 years duration. This diagnosis can be established utilizing the SCID-I, direct clinical assessments, family, informants, and confirmation of diagnosis from clinical sources. These may include medical records, confirmation of diagnosis by treating clinician through telephone contact, or written confirmation from treating clinic. If the listed sources are not available, other sources of diagnostic confirmation may also be acceptable after discussion with the medical monitor.
* Treated with atypical antipsychotic drug (in any approved dosage form) other than Clozapine at a stable dose for at least 8 weeks prior to screening and be clinically stable; the subject must remain clinically stable (in the opinion of the principal investigator) through randomization. The use of up to 2 atypical antipsychotic drugs is permitted, as long as in the opinion of the investigator, the second medication is not required to control treatment-resistant or intractable psychotic symptoms. No subject will be washed off antipsychotic therapy to become eligible for this study.
* Schizophrenia clinical symptom burden severity defined by the following: a Brief Psychiatric Rating Scale (BPRS) Conceptual Disorganization item score = 4; and a BPRS Hallucinatory Behavior item score = 5, or an Unusual Thought Content item score = 5. Either Hallucinatory Behavior or Unusual Thought Content, but not both, may have a score of 6 (but not > 6).
* Simpson-Angus Scale (SAS) total score = 6
* Calgary Depression Scale for Schizophrenia (CDSS) total score = 10
* General health status acceptable for participation in a 26-week clinical study
* Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study
* Fluency (oral and written) in the language in which the standardized tests will be administered
* The ability to refrain from using any tobacco or other nicotine-containing products for at least 30 minutes before any cognitive testing
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hospitalization within 12 weeks before screening or during the screening period, or change of antipsychotic medication or dose within 8 weeks before screening or during the screening period.
* Participation in another therapeutic (medication administration) clinical study within the past 2 months.
* Psychiatric hospitalization or incarcerations due to breakthrough symptoms or acute exacerbations for a period of 3 months before screening. Subjects with a recent "social" hospitalization or incarceration may be entered into screening after consultation with the medical monitor
* Likelihood, in the opinion of the investigator, that either the subject or informant will be unable to complete a 26-week study
* Treatment with prohibited antipsychotic drug, and/or treatment with more than 2 permitted antipsychotic drugs. Treatment with a first-generation antipsychotic drug (typical antipsychotic) is prohibited unless it is administered at a low dose after discussion with the medical monitor
* Current treatment with any anticholinergic agent
* Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria met for alcohol abuse within the past 3 months or substance abuse (other than nicotine) within the last 6 months before screening
* Significant suicide risk as defined by 1) suicidal ideation as endorsed on items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past year; 2) suicidal behavior detected by the C-SSRS during the past 2 years, or 3) psychiatric interview and examination
* Stroke within 6 months before screening, history of brain tumor, subdural hematoma, or other clinically significant neurological condition, head trauma with loss of consciousness within 12 months before screening
* Monoamine oxidase inhibitor antidepressants or tricyclic medications used in antidepressant doses are excluded. Other antidepressant medications are allowed if the subject has been treated with a stable dose for at least 3 months before screening
* Immunosuppressants, mood stabilizers, chronic use of a sedative hypnotic drug, chronic intake of clinically significant doses of opioid containing analgesics or any current methadone treatment all in the judgment of the investigator may be permitted depending on the circumstance
* Use of Central Nervous System(CNS) stimulants
* Nicotine therapy (including patches), varenicline (Chantix), or similar therapeutic agent within the last six months before screening
* Use of a benzodiazepine medication is allowed if the subject has not had a change in medication or dose for at least 3 months. For subjects prescribed benzodiazepines, short-acting benzodiazepines are to be used whenever possible. Use of longer-acting benzodiazepines may be acceptable if prior authorization is obtained from the medical monitor. When possible, benzodiazepines should not be administered within 3 hours before cognitive testing. The use of more than one sedative-hypnotic medication is not allowed.

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 assessing the outcomes
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
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
753
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Mississippi
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Caba
Country [22] 0 0
Argentina
State/province [22] 0 0
Cordoba
Country [23] 0 0
Argentina
State/province [23] 0 0
Mendoza
Country [24] 0 0
Brazil
State/province [24] 0 0
SP
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio de Janeiro
Country [26] 0 0
Brazil
State/province [26] 0 0
Sao Paulo
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Germany
State/province [31] 0 0
Achim
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Dusseldorf
Country [34] 0 0
Germany
State/province [34] 0 0
Freiburg
Country [35] 0 0
Germany
State/province [35] 0 0
Leipzig
Country [36] 0 0
Germany
State/province [36] 0 0
Mittweida
Country [37] 0 0
Germany
State/province [37] 0 0
Munchen
Country [38] 0 0
Germany
State/province [38] 0 0
Regebsburg
Country [39] 0 0
Germany
State/province [39] 0 0
Regensburg
Country [40] 0 0
Germany
State/province [40] 0 0
Stralsund
Country [41] 0 0
Germany
State/province [41] 0 0
Wiesbaden
Country [42] 0 0
Mexico
State/province [42] 0 0
D.F
Country [43] 0 0
Mexico
State/province [43] 0 0
Jalisco
Country [44] 0 0
Mexico
State/province [44] 0 0
Neuvo Leon
Country [45] 0 0
Poland
State/province [45] 0 0
Bialystok
Country [46] 0 0
Poland
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Gdansk
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Poland
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Lodz
Country [48] 0 0
Poland
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Lublin
Country [49] 0 0
Poland
State/province [49] 0 0
Torun
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Poland
State/province [50] 0 0
Tuszyn
Country [51] 0 0
Poland
State/province [51] 0 0
Warszawa
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Arkangelsk region
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Moscow
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Saint-Petersburg
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Stavropol
Country [56] 0 0
Serbia
State/province [56] 0 0
Belgrade
Country [57] 0 0
Serbia
State/province [57] 0 0
Kragujevac
Country [58] 0 0
Serbia
State/province [58] 0 0
Nis
Country [59] 0 0
Serbia
State/province [59] 0 0
Novi Knezevac
Country [60] 0 0
Singapore
State/province [60] 0 0
Singapore
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Castilla y Leon
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Pontevedra
Country [65] 0 0
Ukraine
State/province [65] 0 0
Donetsk
Country [66] 0 0
Ukraine
State/province [66] 0 0
Ivano-Frankivsk
Country [67] 0 0
Ukraine
State/province [67] 0 0
Kharkiv
Country [68] 0 0
Ukraine
State/province [68] 0 0
Kyiv
Country [69] 0 0
Ukraine
State/province [69] 0 0
Lugansk

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
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
NeuroCog Trials, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01714661