Text Size

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

This study has been completed.
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
EnVivo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00968851
First received: August 28, 2009
Last updated: March 5, 2012
Last verified: March 2012
History of Changes

August 28, 2009
March 5, 2012
December 2009
January 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]
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 taking chronic stable atypical anti-psychotic therapy. Cognitive [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00968851 on ClinicalTrials.gov Archive Site
Assessment of Clinical Efficacy [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia
A Randomized, Double-Blind, Placebo-Controlled, Parallel, 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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Central Nervous System Diseases
  • Cognition
  • Drug: EVP-6124
    Arms: 1
  • Drug: Placebo
    Arm: 3
  • Drug: EVP-6124
    Arms: 2
  • Active Comparator: EVP-6124 0.3 mg
    one 0.3 mg capsule every day for 84 days
    Intervention: Drug: EVP-6124
  • Active Comparator: EVP-6124 1.0 mg
    one 1.0 mg capsule every day for 84 days.
    Intervention: Drug: EVP-6124
  • Placebo Comparator: Placebo
    Placebo every day for 84 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
317
March 2011
January 2011   (final data collection date for primary outcome measure)

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: SANS item ≤3
  • 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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation,   Serbia,   Ukraine
 
NCT00968851
EVP-6124-009
No
EnVivo Pharmaceuticals, Inc.
EnVivo Pharmaceuticals, Inc.
INC Research
Study Director: Chris Southard INC Research
EnVivo Pharmaceuticals, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP