Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia (PRISMA-2)

ROVI

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Treatments

Drug: Risperidone ISM

Study type

Interventional

Funder types

Industry

Identifiers

NCT02086786

ROV-RISP-2011-02

Details and patient eligibility

About

To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting formulation (in situ microparticle, ISM) of risperidone over four IM injections in the gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients with schizophrenia.

Full description

This was a multicenter, open-label, two-arm, parallel-design, repeat-dose clinical study designed to evaluate the PK, safety, and tolerability of Risperidone ISM®, a new long-acting injectable formulation of the licensed drug risperidone, administered in the gluteal muscle or the deltoid muscle. Participants were patients with a diagnosis of schizophrenia capable of understanding, signing, and consenting to study participation on their own.

Objectives:

Primary Objective

• To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting formulation of risperidone over four IM injections in the gluteal and deltoid muscle at 28 day intervals and at one dose strength (75 mg) in patients with schizophrenia.

Secondary Objectives

To document the attainment of steady-state exposure by the injectable formulation ISM® of risperidone over four IM injections in the gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients with schizophrenia.
To perform a descriptive comparison of the PK data between the gluteal and the deltoid muscle administration of the injectable formulation ISM® of risperidone over four IM injections at 28-day intervals and at one dose strength (75 mg) in patients with schizophrenia.
To evaluate the safety and tolerability of the injectable formulation ISM® of risperidone after four IM injections in the gluteal muscle or deltoid muscle at 28-day intervals at one dose strength (75 mg) in patients with schizophrenia.

Exploratory Objectives

To explore the efficacy of once every four weeks of the injectable formulation ISM® of risperidone after four IM injections in the gluteal muscle or deltoid muscle at 28-day (± 1 day) intervals at one dose strength (75 mg) in patients with schizophrenia.
To characterize patients' metabolic phenotype (cytochrome P450 [CYP]2D6, CYP3A4) to explain any potential unexpected outlying PK value, and/or explore its relationship with any potential safety or tolerability issue.

Enrollment

70 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Capable of providing informed consent.
Male or female aged ≥18 years to ≤65 years.
Current diagnosis of schizophrenia, according to Diagnostic and Statistical Manual
Body mass index (BMI) ≥17 kg/m2 but ≤35 kg/m2.
Medically stable over the last month, and psychiatrically stable
On oral stable dosage of risperidone ≥4 mg daily as maintenance therapy.
Total score ≤70 on the Positive and Negative Syndrome Scale.
Using a medically accepted contraceptive method
Agrees to washout all prohibited medications prior to baseline (day -1)

Exclusion criteria

Informed consent obtained from a third party.
Prisoners or patients who are compulsorily detained.
Females who are breast-feeding and/or who have a positive pregnancy test.
Presence of an uncontrolled, unstable clinically significant medical condition.
Positive serology for Hepatitis B, Hepatitis C or anti-HIV 1 and 2 at screening.
History of neuroleptic malignant syndrome.
Current or past history of tardive dyskinesia.
Positive urine drug or alcohol screen finding.
Risk of committing self-harm or harm based on Columbia Suicidal Rating Scale.
Taking more than one antidepressant.
Use of depot antipsychotics within the last three months.
Use of strong or moderate cytochrome P450 isoenzyme 3A4inducers
Use of electroconvulsive therapy (ECT) within the last three months.
Receipt of any investigational drugs within the last three months.
Known or suspected allergy or hypersensitivity to risperidone
Previous non-responder to risperidone treatment.