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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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Central Nervous System Diseases
Cognition
 Drug: EVP-6124
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EnVivo Pharmaceuticals, Inc.:

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. [ Time Frame: 84 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of Clinical Efficacy [ Time Frame: 84 days ] [ Designated as safety issue: No ]

Enrollment: 317
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EVP-6124 0.3 mg
one 0.3 mg capsule every day for 84 days
 Drug: EVP-6124
Arms: 1
Active Comparator: EVP-6124 1.0 mg
one 1.0 mg capsule every day for 84 days.
 Drug: EVP-6124
Arms: 2
Placebo Comparator: Placebo
Placebo every day for 84 days
 Drug: Placebo
Arm: 3

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968851

  Show 31 Study Locations
Sponsors and Collaborators
EnVivo Pharmaceuticals, Inc.
INC Research
Investigators
Study Director: Chris Southard INC Research
  More Information

No publications provided

Responsible Party: EnVivo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00968851     History of Changes
Other Study ID Numbers: EVP-6124-009
Study First Received: August 28, 2009
Last Updated: March 5, 2012
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by EnVivo Pharmaceuticals, Inc.:
Schizophrenia
Central nervous System Diseases
Cognition

Additional relevant MeSH terms:
Central Nervous System Diseases
Nervous System Diseases
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Nicotinic Agonists
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013