Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia

Schizophrenia Clinical Trial

— PRISMA-2  

Official title:

Multicenter, Open-label, Two-arm, Parallel-design, Repeat-dose Clinical Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Four Intramuscular Injections of Risperidone ISM® 75 mg, at 28 Day Intervals in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086786
• Other study ID #: ROV-RISP-2011-02
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2014
• Last updated: May 4, 2015
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Rovi Pharmaceuticals Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Capable of providing informed consent.

2. Male or female aged =18 years to =65 years.

3. Current diagnosis of schizophrenia, according to Diagnostic and Statistical Manual

4. Body mass index (BMI) =17 kg/m2 but =35 kg/m2.

5. Medically stable over the last month, and psychiatrically stable

6. On oral stable dosage of risperidone =4 mg daily as maintenance therapy.

7. Total score =70 on the Positive and Negative Syndrome Scale.

8. Using a medically accepted contraceptive method

9. Agrees to washout all prohibited medications prior to baseline (day -1)

Exclusion Criteria:

1. Informed consent obtained from a third party.

2. Prisoners or patients who are compulsorily detained.

3. Females who are breast-feeding and/or who have a positive pregnancy test.

4. Presence of an uncontrolled, unstable clinically significant medical condition.

5. Positive serology for Hepatitis B, Hepatitis C or anti-HIV 1 and 2 at screening.

6. History of neuroleptic malignant syndrome.

7. Current or past history of tardive dyskinesia.

8. Positive urine drug or alcohol screen finding.

9. Risk of committing self-harm or harm based on Columbia Suicidal Rating Scale.

10. Taking more than one antidepressant.

11. Use of depot antipsychotics within the last three months.

12. Use of strong or moderate cytochrome P450 isoenzyme 3A4inducers

13. Use of electroconvulsive therapy (ECT) within the last three months.

14. Receipt of any investigational drugs within the last three months.

15. Known or suspected allergy or hypersensitivity to risperidone

16. Previous non-responder to risperidone treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Risperidone ISM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rovi Pharmaceuticals Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Month 4		From Pre-dose to month 4; 3 timepoints Post-Dose 1, Pre-dose and 1 timepoint after Doses 2, 3 and 4 wtihin a timeframe of 28 days.	No
Primary	Peak Plasma Concentration (Cmax) for Active Moiety		Pre-dose and 204 days Post-dose (32 time points will be carried out within).	No
Primary	Trough Plasma Concentration (Cmin) for Active Moiety		Pre-dose and 204 days Post-dose (32 time points will be carried out within).	No
Primary	Area under the curve to the last quantified concentration (AUClast) and Area under the curve extrapolated to infinity (AUC8) for Active Moiety		Pre-dose and 204 days Post-dose (32 time points will be carried out within).	No
Primary	Terminal rate constant (?z), Terminal half-life (t1/2) and Time to peak concentration (tmax) for Active Moiety		Pre-dose and 204 days Post-dose (32 time points will be carried out within).	No
Secondary	Peak Plasma Concentration (Cmax) for Risperidone and 9OH-Risperidone Moieties		Pre-dose and 204 days Post-dose (32 time points will be carried out within).	No
Secondary	Trough Plasma Concentration (Cmin) for Risperidone and 9OH-Risperidone Moieties		Pre-dose and 204 days Post-dose (32 time points will be carried out within).	No
Secondary	Occurrence, nature, onset time, duration, intensity, action taken, outcome and relationship to study drug of AEs as a Measure of Safety		Pre-dose and 204 days Post-dose (32 time points will be carried out within).	Yes
Secondary	Area under the curve to the last quantified concentration (AUClast) and Area under the curve extrapolated to infinity (AUC8) for Risperidone and 9OH-Risperidone Moieties		Pre-dose and 204 days Post-dose (32 time points will be carried out within).	No
Secondary	Terminal rate constant (?z), Terminal half-life (t1/2) and Time to peak concentration (tmax) for Risperidone and 9OH-Risperidone Moieties		Pre-dose and 204 days Post-dose (32 time points will be carried out within).	No
Secondary	Area Under the Concentration-time Curve for To perform a descriptive comparison of the PK data between the gluteal and the deltoid muscle administration of the injectable ISM formulation		Pre-dose and 204 days Post-dose (32 time points will be carried out within).	No