CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
EVP-6124 (0.3 mg/day) +3 moredrug
Likely dose
EVP-6124 (0.3 mg/day)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01556763
NCT01556763Phase 1Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled Randomized Study to Assess the Safety, Tolerability, and Pharmacokinetics of EVP-6124 in Participants With Schizophrenia on Stable Monotherapy With Selected Antipsychotics

FORUM Pharmaceuticals Inc·interventional·Posted Mar 16, 2012·Updated Jun 21, 2012

In Brief

A Phase 1 clinical trial evaluating EVP-6124 (0.3 mg/day), EVP-6124 (1.0 mg/day), and 2 other interventions for Schizophrenia and 2 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder, Central Nervous System Diseases
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 16, 2012
Enrollment StartApr 1, 2008
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.3 years ago

Interventions

EVP-6124 (0.3 mg/day)drug

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

EVP-6124 (1.0 mg/day)drug

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

Placebodrug

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

Antipsychotic therapydrug

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.