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

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

Conditions
SchizophreniaSchizoaffective DisorderCentral Nervous System Diseases
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.

Trial Locations (1)

67211

Clinical Research Institute, Wichita

Sponsors
All Listed Sponsors
lead

FORUM Pharmaceuticals Inc

INDUSTRY