SchizophreniaPhase 2PRISMA-2NCT02086786

Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia

A Phase 2 study testing Risperidone ISM in people with Schizophrenia, run by Rovi Pharmaceuticals Laboratories at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Risperidone ISM
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: Mar 2014to Mar 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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)

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

St Louis Clinical Trials, LC
St Louis, Missouri, 63141

Other trials in United States

About this study

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

Read the detailed 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.

Conditions: Schizophrenia
Being tested: Risperidone ISM
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Risperidone ISMDrug
Also called No other names
Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.

Study groups in NCT02086786
Study group	Role	What they receive
Gluteus (Risperidone ISM)	Experimental	Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals Receives: Drug: Risperidone ISM
Deltoid (Risperdione ISM)	Experimental	Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals Receives: Drug: Risperidone ISM

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Plasma Concentration (Cmax) for Active Moiety
Measured: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
Trough Plasma Concentration (Cmin) for Active Moiety
Measured: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
Area Under the Curve to the Last Quantified Concentration (AUClast) for Active Moiety
Measured: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
Area Under the Curve Extrapolated to Infinity (AUC∞) for Active Moiety
Measured: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
AUCτ for Active Moiety
AUCτ is the area under the curve over the dosing interval (τ), where the dosing interval is 28 days
Measured: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
Time to Peak Concentration (Tmax) for Active Moiety
Measured: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
Terminal Half-life (t1/2) for Active Moiety
Measured: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
PTF for Active Moiety
Peak to Trough Fluctuation ratio for the Active Moiety
Measured: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.

Secondary outcomes (1)

Accumulation Ratio (RA) for Active Moiety
Defined as AUC (0-28 days) after the 4th dose divided by the AUC (0-28 days) of the first dose.
Measured: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Mar 2015

First posted13 Mar 2014 (estimated)
Study startMar 2014
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02086786
Sponsor's protocol ID: ROV-RISP-2011-02
Acronym: PRISMA-2
Status last verified: May 2015
First submitted: 10 Feb 2014
Last updated: 13 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Open-label, Two-arm, Parallel-design, Repeat-dose Clinical Trial to Evaluate the PK, Safety, and Tolerability of Four Intramuscular Injections of Risperidone ISM® 75 mg, at 28 Day Intervals in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT02086786
Acronym / sponsor ID: PRISMA-2 / ROV-RISP-2011-02
Conditions: Schizophrenia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 13 Mar 2014 (estimated)
Results: Posted 13 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Gluteus (Risperidone ISM)	Experimental	Drug: Risperidone ISMRisperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Deltoid (Risperdione ISM)	Experimental	Drug: Risperidone ISMRisperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Risperidone ISMAlso: No other namesFour doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals. Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.	Drug	Deltoid (Risperdione ISM), Gluteus (Risperidone ISM)

Primary outcome

Peak Plasma Concentration (Cmax) for Active Moiety
Time frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
Trough Plasma Concentration (Cmin) for Active Moiety
Time frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
Area Under the Curve to the Last Quantified Concentration (AUClast) for Active Moiety
Time frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
Area Under the Curve Extrapolated to Infinity (AUC∞) for Active Moiety
Time frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
AUCτ for Active Moiety
Time frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
AUCτ is the area under the curve over the dosing interval (τ), where the dosing interval is 28 days
Time to Peak Concentration (Tmax) for Active Moiety
Time frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
Terminal Half-life (t1/2) for Active Moiety
Time frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
PTF for Active Moiety
Time frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
Peak to Trough Fluctuation ratio for the Active Moiety

1 secondary outcome

Accumulation Ratio (RA) for Active Moiety
Time frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.

Results and safety

Results posted to the registry on 13 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gluteus (Risperidone ISM)	35	17
Deltoid (Risperdione ISM)	35	19

Primary outcome: Peak Plasma Concentration (Cmax) for Active Moiety

Time frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Gluteus (Risperidone ISM) n = 20	Deltoid (Risperdione ISM) n = 23
Dose 1	39.6 (33.7)	54.1 (48.9)
Dose 2	53.2 (52.7)	61.0 (38.4)
Dose 3	48.6 (33.3)	61.0 (36.9)
Dose 4	47.4 (38.9)	57.7 (39.3)

Population analysed: The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.

Primary outcome: Trough Plasma Concentration (Cmin) for Active Moiety

Measure	Gluteus (Risperidone ISM) n = 20	Deltoid (Risperdione ISM) n = 23
Dose 1	11.1 (72.6)	7.0 (87.6)
Dose 2	7.86 (90.1)	8.60 (49.4)
Dose 3	9.97 (70.7)	10.2 (57.6)
Dose 4	12.6 (59.1)	9.52 (56.5)

Primary outcome: Area Under the Curve to the Last Quantified Concentration (AUClast) for Active Moiety

Measure	Gluteus (Risperidone ISM) n = 18	Deltoid (Risperdione ISM) n = 22
Value	21300 (35.2)	23300 (43.3)

Population analysed: The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 18 patients in the gluteal and 22 in the deltoids had concentration amenable to evaluation..

Primary outcome: Area Under the Curve Extrapolated to Infinity (AUC∞) for Active Moiety

Measure	Gluteus (Risperidone ISM) n = 11	Deltoid (Risperdione ISM) n = 18
Value	21100 (27.4)	22700 (40.4)

Population analysed: The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 11 patients in the gluteal and 18 in the deltoids had concentration amenable to evaluation.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gluteus (Risperidone ISM)	5 of 34 (14.7%)	32 of 34 (94.1%)	Not reported
Deltoid (Risperdione ISM)	7 of 33 (21.2%)	31 of 33 (93.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jordi Llaudó, M.D study chair

Rovi Laboratorios Farmacéuticos

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Risperidone ISM in people with Schizophrenia, run by Rovi Pharmaceuticals Laboratories at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) for Active Moiety (time frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02086786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.