NCT01556763

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: FORUM Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study drug will be supplied as capsules and will be orally administered once daily for a total of 21 days. Eligible subjects will be admitted to an inpatient study unit on Day -6 (six days before the first dose of study drug is administered) and will remain confined to the inpatient study unit throughout the dosing phase. Safety assessments, PK sampling, and cognitive testing will be performed.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Central Nervous System Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2012-03-16
• Last updated: 2012-06-21
• Results posted: 2012-06-21

Locations

1 site across 1 country: United States