SchizophreniaPhase 2NCT00968851
Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia
A Phase 2 study testing EVP-6124 in people with Schizophrenia and Central Nervous System Diseases, run by FORUM Pharmaceuticals Inc at 31 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Central Nervous System Diseases, Cognition
- What is being tested?
- EVP-6124
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 317 participants
- Where
- 31 sitesin 4 countries
- Study dates
- Dec 2009to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 4 countries.
31 sites in 4 countries
United States14 sites
FutureSearch Clinical Trials, L.P.
Austin, Texas, 78756
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407
Uptown Research Institute
Chicago, Illinois, 60640
InSite Clinical Research
DeSoto, Texas, 75115
Intergrated Medical and Behavioral Associates
Glendale, California, 91204
Alexian Brothers Behavioral Health
Hoffman Estates, Illinois, 60169
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, 37212-8645
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
Excell Research
Oceanside, California, 92056
CBH Health, LLC
Rockville, Maryland, 20850
University of California, San Diego
San Diego, California, 92103
Affiliated Research Institute
San Diego, California, 92108
Schuster Medical Research Institute
Sherman Oaks, California, 91403
CRI Worldwide
Willingboro, New Jersey, 20850
Russia6 sites
Study site
Arkhangelsk, 163530
Study site
Kazan', 420012
Study site
Moscow, 107076
Study site
Moscow, 115522
Study site
Saint Petersburg, 190121
Study site
Stavropol, 355108
Ukraine6 sites
Study site
Crimea, 95006
Study site
Dnipro, 49005
Study site
Kiev, 02660
Study site
Kiev, 04080
Study site
Odesa, 65014
Study site
Vinnytsia, 21005
Serbia5 sites
Clinical Site 1
Belgrade, 11000
Clinical Site 2
Belgrade, 11000
Clinical Site 3
Belgrade, 11000
Study site
Kragujevac, 34000
Study site
Niš, 18000
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia, Central Nervous System Diseases, Cognition
- Being tested
- EVP-6124, Placebo
- Keywords
- Schizophrenia, Central nervous System Diseases, Cognition
- Medical subject headings
- Schizophrenia, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVP-6124Drug
Arms: 1
PlaceboDrug
Arm: 3
EVP-6124Drug
Arms: 2
| Study group | Role | What they receive |
|---|---|---|
| EVP-6124 0.3 mg | Active comparator | one 0.3 mg capsule every day for 84 days Receives: Drug: EVP-6124 |
| EVP-6124 1.0 mg | Active comparator | one 1.0 mg capsule every day for 84 days. Receives: Drug: EVP-6124 |
| Placebo | Placebo comparator | Placebo every day for 84 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 84 days
Secondary outcomes (1)
Assessment of Clinical Efficacy
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- FORUM Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Chris Southard, Study director, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968851
- Sponsor's protocol ID
- EVP-6124-009
- Status last verified
- Mar 2012
- First submitted
- 28 Aug 2009
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28433500
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00968851
- Acronym / sponsor ID
- EVP-6124-009
- Conditions
- Schizophrenia, Central Nervous System Diseases, Cognition
- Keywords
- Schizophrenia, Central nervous System Diseases, Cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- FORUM Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EVP-6124 0.3 mg | Active comparator | Drug: EVP-6124one 0.3 mg capsule every day for 84 days |
| EVP-6124 1.0 mg | Active comparator | Drug: EVP-6124one 1.0 mg capsule every day for 84 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo every day for 84 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVP-6124Arms: 1 | Drug | EVP-6124 0.3 mg |
| PlaceboArm: 3 | Drug | Placebo |
| EVP-6124Arms: 2 | Drug | EVP-6124 1.0 mg |
Primary outcome
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
1 secondary outcome
Assessment of Clinical Efficacy
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
- Derived from this study: PubMed 28433500Georgiades 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Southard study director
Syneos Health
31 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVP-6124 in people with Schizophrenia and Central Nervous System Diseases, run by FORUM Pharmaceuticals Inc at 31 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Russia, Ukraine, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00968851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2014.