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

Sponsor:	EnVivo Pharmaceuticals, Inc.
Collaborator:	INC Research Limited
Information provided by:	EnVivo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00968851

Purpose

This study is being conducted to determine the safety and tolerability 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, cognitive performance and behavioral and psychotic symptoms will be evaluated.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Neurologic Diseases Psychotic Disorders Schizophrenia

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 ]

Estimated Enrollment:	225
Study Start Date:	October 2009
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
EVP-6124 0.3 mg: Active Comparator one 0.3 mg capsule every day for 84 days	Drug: EVP-6124 Arms: 1, 2
EVP-6124 1.0 mg: Active Comparator one 1.0 mg capsule every day for 84 days.	Drug: EVP-6124 Arms: 1, 2
Placebo: Placebo Comparator Placebo every day for 84 days	Drug: EVP-6124 Arms: 1, 2 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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	EnVivo Pharmaceuticals, Inc. ( Maria Gawryl, Ph.D., Executive Director, Clinical Development & Regulatory Affairs )
Study ID Numbers:	EVP-6124-009
Study First Received:	August 28, 2009
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00968851 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by EnVivo Pharmaceuticals, Inc.:

Schizophrenia
Central nervous System Diseases
Cognition

Additional relevant MeSH terms:

Schizophrenia
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Mental Disorders
Nicotinic Agonists

Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Cholinergic Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010