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SchizophreniaPhase 3NCT01714661

Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy

A Phase 3 study testing EVP-6124 in people with Schizophrenia and Impaired Cognition, run by FORUM Pharmaceuticals Inc at 94 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic therapy. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Schizophrenia, Impaired 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
753 participants
Where
94 sitesin 13 countries
Study dates
Oct 2012to Dec 2015
Phase
Phase 3
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

94 sites in 13 countries.

94 sites in 13 countries

United States38 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anaheim, California

  • Study site

    Atlanta, Georgia

  • Study site

    Bellflower, California

  • Study site

    Cedarhurst, New York

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    Conshohocken, Pennsylvania

  • Study site

    Costa Mesa, California

  • Study site

    Creve Coeur, Missouri

  • Study site

    Culver City, California

  • Study site

    Dallas, Texas

  • Study site

    Downey, California

  • Study site

    Durham, North Carolina

  • Study site

    Escondido, California

  • Study site

    Flowood, Mississippi

  • Study site

    Lauderhill, Florida

  • Study site

    Los Angeles, California

  • Study site

    Marlton, New Jersey

  • Study site

    Miami, Florida

  • Study site

    Minneapolis, Minnesota

  • Study site

    New York, New York

  • Study site

    Norristown, Pennsylvania

  • Study site

    North Miami, Florida

  • Study site

    O'Fallon, Missouri

  • Study site

    Oceanside, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Orange City, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    San Diego, California

  • Study site

    Shreveport, Louisiana

  • Study site

    St Louis, Missouri

  • Study site

    Torrance, California

  • Study site

    Tucson, Arizona

  • Study site

    Wichita, Kansas

Other trials in United States

Germany11 sites

  • Study site

    Achim

  • Study site

    Berlin

  • Study site

    Düsseldorf

  • Study site

    Freiburg im Breisgau

  • Study site

    Leipzig

  • Study site

    Mittweida

  • Study site

    München

  • Study site

    Regebsburg

  • Study site

    Regensburg

  • Study site

    Stralsund

  • Study site

    Wiesbaden

Other trials in Germany

Spain8 sites

  • Study site

    Alcorcón, Madrid

  • Study site

    Barcelona, Barcelona

  • Study site

    Coslada, Madrid

  • Study site

    Madrid, Madrid

  • Study site

    Mataró, Barcelona

  • Study site

    Salamanca, Castille and León

  • Study site

    Vigo, Pontevedra

  • Study site

    Zamora, Castille and León

Other trials in Spain

Poland7 sites

  • Study site

    Bialystok

  • Study site

    Gdansk

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Torun

  • Study site

    Tuszyn

  • Study site

    Warsaw

Other trials in Poland

Canada5 sites

  • Study site

    Calgary, Alberta

  • Study site

    Chatham, Ontario

  • Study site

    Kingston, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Penticton, British Columbia

Other trials in Canada

Ukraine5 sites

  • Study site

    Donetsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Luhansk

Other trials in Ukraine

Argentina4 sites

  • Study site

    Caba, Buenos Aires F.D.

  • Study site

    Córdoba, Córdoba Province

  • Study site

    La Plata, Buenos Aires

  • Study site

    Mendoza, Mendoza Province

Other trials in Argentina

Russia4 sites

  • Study site

    Moscow, Moscow

  • Study site

    Saint Petersburg, Sankt-Peterburg

  • Study site

    Stavropol

  • Study site

    Talagi, Arkhangelskaya oblast

Other trials in Russia

Serbia4 sites

  • Study site

    Belgrade

  • Study site

    Kragujevac

  • Study site

    Niš

  • Study site

    Novi Kneževac

Other trials in Serbia

Brazil3 sites

  • Study site

    Itapira, São Paulo

  • Study site

    Rio de Janeiro, Rio de Janeiro

  • Study site

    São Paulo

Other trials in Brazil

Mexico3 sites

  • Study site

    Guadalajara, Jalisco

  • Study site

    México, D.F

  • Study site

    Monterrey, Neuvo Leon

Other trials in Mexico

Australia1 site

  • Study site

    Melbourne

Other trials in Australia

Singapore1 site

  • Study site

    Singapore, Singapore

Other trials in Singapore

About this study

Official 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

The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic therapy.

Being tested
EVP-6124, Placebo
Keywords
Schizophrenia, Cognition, Cognition Impairment, Alpha-7 nAChR
Medical subject headings
Schizophrenia, Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EVP-6124Drug

    Arms 1, 2

  • PlaceboDrug

    Arm 3

Study groups in NCT01714661
Study groupRoleWhat they receive
EVP-6124, low doseExperimentallow dose, Tablet, Once Daily, Day 1 through Day 182
Receives: Drug: EVP-6124
EVP-6124, high doseExperimentalhigh dose, Tablet, Once Daily, Day 1 through Day 182
Receives: Drug: EVP-6124
EVP-6124, PlaceboPlacebo comparatorPlacebo, Tablet, Once Daily, Day -14 through Day 182
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) to Day 182

    Measured: Baseline to Day 182 or Early Termination

  2. Change from Baseline in the Schizophrenia Cognition Rating Scale (SCoRs) to Day 182

    Measured: Baseline to Day 182 or Early Terminiation

  3. Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia

    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)

    Measured: Screening (Day -42 to Day -15) to Day 182 or Early Terminiation

Secondary outcomes (4)

  1. Change from Baseline in the Positive and Negative Symptom Scale (PANSS) to Day 182

    Measured: Baseline to Day 182 or Early Termination

  2. Change from Baseline in the Clinical Global Impression-Severity (CGI-S) to Day 182

    Measured: Baseline to Day 182 or Early Termination

  3. Change from Baseline in the Clinical Global Impression Change Scale (CGI-C) to Day 182

    Measured: Baseline to Day 182 or Early Termination

  4. Change from Baseline in the EuroQOL-5D (EQ-5D) to Day 182

    Measured: Baseline to Day 182 or Early Termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
753 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01714661
Sponsor's protocol ID
EVP-6124-015
Other IDs
2012-003208-10
Status last verified
Jun 2015
First submitted
19 Oct 2012
Last updated
3 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EVP-6124 in people with Schizophrenia and Impaired Cognition, run by FORUM Pharmaceuticals Inc at 94 sites in 13 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 12 inclusion and 14 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 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Germany, Spain, Poland, Canada and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change from Baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) to Day 182 (time frame: Baseline to Day 182 or Early Termination). The study lists 3 primary outcomes in all. 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 NCT01714661.

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 3 May 2016.

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