Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005307

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005307
  •   2013/11/18
  •   2012/10/19
  •   no
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Secondary IDs

  •   2012-003208-10 
  •   NCT01714661  (ClinicalTrials.gov)
  •   EVP-6124-015  (EnVivo Pharmaceuticals, Inc.)
  •   2012-003208-10 
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Health Condition or Problem studied

  •   Schizophrenia
  •   Impaired Cognition
  •   F20.9 -  Schizophrenia, unspecified
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Interventions/Observational Groups

  •   Drug: EVP-6124
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- 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
- Change from Baseline in the Schizophrenia Cognition Rating Scale (SCoRs) to Day 182; time frame: Baseline to Day 182 or Early Terminiation
- Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia; time frame: Screening (Day -42 to Day -15) to Day 182 or Early Terminiation; 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)

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Secondary Outcome

- Change from Baseline in the Positive and Negative Symptom Scale (PANSS) to Day 182; time frame: Baseline to Day 182 or Early Termination
- Change from Baseline in the Clinical Global Impression-Severity (CGI-S) to Day 182; time frame: Baseline to Day 182 or Early Termination
- Change from Baseline in the Clinical Global Impression Change Scale (CGI-C) to Day 182; time frame: Baseline to Day 182 or Early Termination
- Change from Baseline in the EuroQOL-5D (EQ-5D) to Day 182; time frame: Baseline to Day 182 or Early Termination

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Canada
  •   Germany
  •   Mexico
  •   Poland
  •   Russian Federation
  •   Serbia
  •   Singapore
  •   Spain
  •   Ukraine
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Locations of Recruitment

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Recruitment

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  •   2012/10/31
  •   700
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   50   Years
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Additional 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

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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.

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Addresses

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    • FORUM Pharmaceuticals Inc
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    • INC Research
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    •   [---]*
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    • NeuroCog Trials, Inc.
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    • INC Research, LLC 
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    • INC Research, LLC 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2014/09/30
* This entry means the parameter is not applicable or has not been set.