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Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia

Primary Purpose

Schizophrenia, Central Nervous System Diseases, Cognition

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EVP-6124
Placebo
EVP-6124
Sponsored by
FORUM Pharmaceuticals Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Central nervous System Diseases, Cognition

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who meet clinical criteria for schizophrenia or schizo-affective disorder utilizing the structured clinical interview (SCI)
  • Must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks
  • Must have no more than "moderate" severity rating for negative symptoms: BPRS item ≤4
  • A minimal level of extrapyramidal symptoms (EPS); Simpson-Angus Scale total score ≤6
  • A minimal level of depression; Calgary Depression Scale total score ≤10
  • Must have a general health status acceptable for participation in a 12-week clinical trial
  • Fluency (oral and written) in the language in which the standardized tests will be administered
  • If a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing

Exclusion Criteria:

General

  • Insufficiently controlled diabetes mellitus in the judgment of the investigator
  • Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ
  • Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
  • Unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction

Sites / Locations

  • Intergrated Medical and Behavioral Associates
  • Excell Research
  • University of California, San Diego
  • Affiliated Research Institute
  • Schuster Medical Research Institute
  • Scientific Clinical Research, Inc.
  • Uptown Research Institute
  • Alexian Brothers Behavioral Health
  • CBH Health, LLC
  • CRI Worldwide
  • Carolina Clinical Trials, Inc.
  • Vanderbilt Psychiatric Hospital
  • FutureSearch Clinical Trials, L.P.
  • InSite Clinical Research
  • Clinical Site 1
  • Clinical Site 2
  • Clinical Site 3

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

EVP-6124 0.3 mg

EVP-6124 1.0 mg

Placebo

Arm Description

one 0.3 mg capsule every day for 84 days

one 1.0 mg capsule every day for 84 days.

Placebo every day for 84 days

Outcomes

Primary Outcome Measures

Safety and efficacy of two doses of EVP-6124 (0.3, and 1.0 mg QD) versus placebo capsules (QD) for 84 days to subjects with schizophrenia who are on chronic stable atypical anti-psychotic therapy as determined by clinical safety and cognitive function.

Secondary Outcome Measures

Assessment of Clinical Efficacy

Full Information

First Posted
August 28, 2009
Last Updated
March 28, 2014
Sponsor
FORUM Pharmaceuticals Inc
Collaborators
Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT00968851
Brief Title
Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia
Official Title
A Randomized Double-Blind Placebo-Controlled 12-Week Phase 2 Study of Two Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist(EVP-6124)or Placebo in Schizophrenia Subjects on Chronic Stable Atypical Anti-Psychotic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FORUM Pharmaceuticals Inc
Collaborators
Syneos Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being conducted to determine the safety and effect on cognitive function of two different doses of an investigational medication, EVP-6124, in individuals with schizophrenia who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and psychotic symptoms will be evaluated.
Detailed Description
This is a randomized, double-blind, placebo-controlled, Phase 2 safety/efficacy study in which two dose levels of EVP-6124 will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for schizophrenia and who are taking chronic atypical anti-psychotic medication at a stable dose. This study will therefore evaluate the effects of EVP-6124 when administered concomitantly with anti-psychotic medication. Patients will be randomized to one of the following groups: 0.3 mg or 1.0 mg EVP-6124, or placebo. Seventy-five patients per group. Study drug will be supplied as capsules and will be orally administered once daily for a total of 84 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Central Nervous System Diseases, Cognition
Keywords
Schizophrenia, Central nervous System Diseases, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVP-6124 0.3 mg
Arm Type
Active Comparator
Arm Description
one 0.3 mg capsule every day for 84 days
Arm Title
EVP-6124 1.0 mg
Arm Type
Active Comparator
Arm Description
one 1.0 mg capsule every day for 84 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo every day for 84 days
Intervention Type
Drug
Intervention Name(s)
EVP-6124
Intervention Description
Arms: 1
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Arm: 3
Intervention Type
Drug
Intervention Name(s)
EVP-6124
Intervention Description
Arms: 2
Primary Outcome Measure Information:
Title
Safety and efficacy of two doses of EVP-6124 (0.3, and 1.0 mg QD) versus placebo capsules (QD) for 84 days to subjects with schizophrenia who are on chronic stable atypical anti-psychotic therapy as determined by clinical safety and cognitive function.
Time Frame
84 days
Secondary Outcome Measure Information:
Title
Assessment of Clinical Efficacy
Time Frame
84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who meet clinical criteria for schizophrenia or schizo-affective disorder utilizing the structured clinical interview (SCI) Must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks Must have no more than "moderate" severity rating for negative symptoms: BPRS item ≤4 A minimal level of extrapyramidal symptoms (EPS); Simpson-Angus Scale total score ≤6 A minimal level of depression; Calgary Depression Scale total score ≤10 Must have a general health status acceptable for participation in a 12-week clinical trial Fluency (oral and written) in the language in which the standardized tests will be administered If a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing Exclusion Criteria: General Insufficiently controlled diabetes mellitus in the judgment of the investigator Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study Unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Southard
Organizational Affiliation
Syneos Health
Official's Role
Study Director
Facility Information:
Facility Name
Intergrated Medical and Behavioral Associates
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Scientific Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Uptown Research Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alexian Brothers Behavioral Health
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
CBH Health, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
CRI Worldwide
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
20850
Country
United States
Facility Name
Carolina Clinical Trials, Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Vanderbilt Psychiatric Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-8645
Country
United States
Facility Name
FutureSearch Clinical Trials, L.P.
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
City
Arkhangelsk
ZIP/Postal Code
163530
Country
Russian Federation
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
City
Stavropol
ZIP/Postal Code
355108
Country
Russian Federation
Facility Name
Clinical Site 1
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Site 2
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Site 3
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
City
Nis
ZIP/Postal Code
18000
Country
Serbia
City
Crimea
ZIP/Postal Code
95006
Country
Ukraine
City
Dnipropetrovs'k
ZIP/Postal Code
49005
Country
Ukraine
City
Kiev
ZIP/Postal Code
02660
Country
Ukraine
City
Kiev
ZIP/Postal Code
04080
Country
Ukraine
City
Odessa
ZIP/Postal Code
65014
Country
Ukraine
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
28433500
Citation
Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
Results Reference
derived

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Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia

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