MedTrace Logo

Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia

NCT01556763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2012-06-21

Study results available
· View outcomes & findings →

Summary

This study in patients with schizophrenia is designed to provide preliminary evidence of the safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2 doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic medication.

Conditions

Interventions

DRUG

EVP-6124 (0.3 mg/day)

EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.

DRUG

EVP-6124 (1.0 mg/day)

EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.

DRUG

Placebo

Matching placebo was administered as one capsule per day for 21 days.

DRUG

Antipsychotic therapy

Concomitant therapy with antipsychotic medication (aripiprazole \[10 to 30 mg/day\], olanzapine \[10 to 20 mg/day\], paliperidone \[3 to 12 mg/day\], or risperidone \[2 to 16 mg/day\]), taken at the same time each day as the EVP-6124 dose. Patients must have been taking concomitant therapy for at least 2 weeks at a stable dose to be eligible for the study.

Sponsors & Collaborators

  • FORUM Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Sheldon H. Preskorn, M.D. · Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01556763 on ClinicalTrials.gov