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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier:
NCT02086786
First received: February 10, 2014
Last updated: May 4, 2015
Last verified: May 2015

February 10, 2014
May 4, 2015
March 2014
March 2015   (Final data collection date for primary outcome measure)
  • Peak Plasma Concentration (Cmax) for Active Moiety [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Trough Plasma Concentration (Cmin) for Active Moiety [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Area under the curve to the last quantified concentration (AUClast) and Area under the curve extrapolated to infinity (AUC∞) for Active Moiety [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Terminal rate constant (λz), Terminal half-life (t1/2) and Time to peak concentration (tmax) for Active Moiety [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
Same as current
Complete list of historical versions of study NCT02086786 on ClinicalTrials.gov Archive Site
  • Peak Plasma Concentration (Cmax) for Risperidone and 9OH-Risperidone Moieties [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Trough Plasma Concentration (Cmin) for Risperidone and 9OH-Risperidone Moieties [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Occurrence, nature, onset time, duration, intensity, action taken, outcome and relationship to study drug of AEs as a Measure of Safety [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Area under the curve to the last quantified concentration (AUClast) and Area under the curve extrapolated to infinity (AUC∞) for Risperidone and 9OH-Risperidone Moieties [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Terminal rate constant (λz), Terminal half-life (t1/2) and Time to peak concentration (tmax) for Risperidone and 9OH-Risperidone Moieties [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • 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 [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
Same as current
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Month 4 [ Time Frame: 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. ]
Same as current
 
Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: Risperidone ISM
  • Experimental: Gluteus (Risperidone ISM)
    Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
    Intervention: Drug: Risperidone ISM
  • Experimental: Deltoid (Risperdione ISM)
    Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
    Intervention: Drug: Risperidone ISM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
March 2015
March 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02086786
ROV-RISP-2011-02
No
Not Provided
Not Provided
Not Provided
Rovi Pharmaceuticals Laboratories
Rovi Pharmaceuticals Laboratories
Not Provided
Not Provided
Rovi Pharmaceuticals Laboratories
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP