Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths (PRISMA-1)

October 19, 2023 updated by: Rovi Pharmaceuticals Laboratories

Phase I, Open-Label, Randomized, Parallel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of One Intramuscular Injection of Risperidone ISM® at Different Dose Strengths in Subjects With Schizophrenia or Schizoaffective Disorder

This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical trial will try to characterize and document the pharmacokinetics of risperidone ISM in schizophrenic or schizoaffective patients after one intramuscular injection at different dose strengths.Likewise, the safety and tolerability of risperidone ISM will be evaluated in the above mentioned population.

Following confirmation of eligibility and a washout period for study-prohibited drugs, a total of 33 subjects will be randomized in a 1:1:1 ratio to receive a single intramuscular (IM) injection of one of the following dosages of study drug:

Group 1: 50 mg risperidone ISM Group 2: 75 mg risperidone ISM Group 3: 100 mg risperidone ISM Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Capable of providing informed consent.
  • Male or female aged ≥ 18 years to < 65 years
  • Current diagnosis of schizophrenia or schizoaffective disorder, according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Clinical Trials (SCID-CT) or the DSM-IV-TR
  • Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment
  • Score of ≤ 4 (moderately ill) on the Clinical Global Impression - Severity of Illness (CGI-S)
  • If a sexually active female of childbearing potential, using a medically accepted contraceptive method.

Exclusion Criteria:

  • Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator may interfere with the interpretation of safety and PK evaluations
  • If female, a positive serum pregnancy test, or planning to become pregnant between now and one month after the last dose of trial medication, or currently breastfeeding a child
  • History of neuroleptic malignant syndrome and current or past history of tardive dyskinesia
  • Positive urine drug/alcohol screen finding, unless the positive finding can be accounted for by documented prescription use.
  • In the investigator's opinion, at imminent risk of committing self-harm
  • Use of depot antipsychotics within the last three months
  • Receipt of any investigational drugs within the last three months
  • Current participation in any other clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Risperidone ISM 50mg
Three different single doses will be evaluated
Drug: Risperidone ISM 50 mg
Other: Risperidone ISM 75mg
Three different single doses will be evaluated
Drug: Risperidone ISM 75 mg
Other: Risperidone ISM 100mg
Three different single doses will be evaluated
Drug: Risperidone ISM 100 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve
Time Frame: Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame
Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rovi Pharmaceuticals Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (Estimated)

February 11, 2013

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROV-RISP-2011-01
  • 2012-003303-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Risperidone ISM 50 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe