Recent Updates
Recently added Catalysts

risperidone IR and LAI formulation

Phase 1

Psychotic Disorders | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: May 21, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

risperidone IR and LAI formulation · 1 trial · 2 indications

Phase 1 1
NCT00821600Characterization of Intramuscular Injections of Risperidone 4 Week Long-acting Injectable (LAI) Formulation in the Buttock of Patients With SchizophreniaPsychotic Disorders
COMPLETED24 Analytics
PHASE1COMPLETED
Characterization of Intramuscular Injections of Risperidone 4 Week Long-acting Injectable (LAI) Formulation in the Buttock of Patients With Schizophrenia
Psychotic Disorders
NCT0082160024
Unlock trial analytics

Study Endpoints

Primary Endpoints

To explore the pharmacokinetics of a 4-week long acting injectable (LAI) formulation of risperidone after single intramuscular (IM) injection of 75 mg in the gluteal muscle.
Up to 85 days for 4-week LAI formulation of risperidone and up to 96 hrs for immediate release (IR) formulation

Secondary Endpoints

To explore safety and tolerability of a 4-week LAI formulation of risperidone by monitoring scores on CGI-S, scores on ESRS, AEs, PE, lab values, ECG values and injection site reactions.
Up to 85 days
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALrisperidone IR and LAI formulation 1 mg risperidone IR single injection followed after 7 to 14 days with 75mg risperidone 4-week-LAI single injection

Interventions

NameTypeDescription
risperidone IR and LAI formulationDRUG1 mg risperidone IR single injection, followed after 7 to 14 days with 75mg risperidone 4-week-LAI single injection
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients with a diagnosis of schizophrenia * Clinically stable with no change in current antipsychotic medications * Meet Positive and Negative Symptom Score (PANSS) and Clinical Global Impression (CGI) score criteria * Have a body mass index (BMI) between 18 and 35 kilogram (...

Countries:United States
Unlock Eligibility Criteria