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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Risperidone ISM 50 mg
Risperidone ISM 75 mg
Risperidone ISM 100 mg
Sponsored by
Rovi Pharmaceuticals Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Pharmacokinetics, Safety, Risperidone ISM®, Intramuscular, Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Risperidone ISM 50mg

Risperidone ISM 75mg

Risperidone ISM 100mg

Arm Description

Three different single doses will be evaluated

Three different single doses will be evaluated

Three different single doses will be evaluated

Outcomes

Primary Outcome Measures

Area under the curve

Secondary Outcome Measures

Full Information

First Posted
February 5, 2013
Last Updated
October 19, 2023
Sponsor
Rovi Pharmaceuticals Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01788774
Brief Title
Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths
Acronym
PRISMA-1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rovi Pharmaceuticals Laboratories

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Pharmacokinetics, Safety, Risperidone ISM®, Intramuscular, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Risperidone ISM 50mg
Arm Type
Other
Arm Description
Three different single doses will be evaluated
Arm Title
Risperidone ISM 75mg
Arm Type
Other
Arm Description
Three different single doses will be evaluated
Arm Title
Risperidone ISM 100mg
Arm Type
Other
Arm Description
Three different single doses will be evaluated
Intervention Type
Drug
Intervention Name(s)
Risperidone ISM 50 mg
Intervention Type
Drug
Intervention Name(s)
Risperidone ISM 75 mg
Intervention Type
Drug
Intervention Name(s)
Risperidone ISM 100 mg
Primary Outcome Measure Information:
Title
Area under the curve
Time Frame
Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Zagreb
Country
Croatia
City
Moscow
Country
Russian Federation
City
Saint Petersburg
Country
Russian Federation
City
Cape Town
Country
South Africa
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths

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