SchizophreniaPhase 1NCT05179525
Comparative Bioavailability of Risperidone.
A Phase 1 study testing Risperidone ISM® 100 mg and Risperdal 4mg Tablet in people with Schizophrenia, run by Rovi Pharmaceuticals Laboratories at 4 sites in United States.
Trial summary
This is an Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany). 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® 100 mg and Risperdal 4mg Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Mar 2021to 17 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subjects will be considered eligible to participate in this study if each one of the following inclusion criteria is satisfied at screening (or at baseline when specified):
- Male or female aged ≥18 and <65 years with a body mass index (BMI) of ≥17 kg/m2 but ≤35 kg/m2
- Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
- Outpatient; not hospitalized for worsening of schizophrenia within the last 3 months (hospitalization for social management within this time period is acceptable)
- Medically stable over the last month and psychiatrically stable without significant symptom exacerbation over the last 3 months based on the investigator's judgement
- On oral risperidone 4 mg daily as maintenance therapy for at least the last 4 weeks prior to screening and on 4 mg oral risperidone once daily QD for at least one week prior baseline (Day1, Visit 2)
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- Agrees to taper off all prohibited medications prior to baseline
- On a stable dosage of all permitted medications (with the exception of medication to be used on an as-needed basis) for at least 2 weeks prior to the baseline visit and for the duration of the study
- Clinical Global Impression - Severity (CGI-S) score of ≤4 (moderately ill)
- A female subject of childbearing potential who is sexually active and using a medically accepted contraceptive method. Acceptable methods include condoms (male or female) with or without spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, and hormonal contraceptives. A female subject of childbearing potential who is not currently sexually active must agree that should she be so while participating in the trial, she will use a medically accepted method of contraception for the remainder of the study and for 1 month afterward. Female patients who have had a hysterectomy, bilateral tubal ligation, or bilateral salpingooophorectomy are considered surgically sterile and are thus are exempt from the requirement to use contraception. Female patients who are postmenopausal are considered not of childbearing potential and thus exempt from the contraception requirement; for the purpose of this study, postmenopausal is defined as the permanent cessation of menstruation for at least 12 months prior to screening in women ≥ 45 years of age.
- Female subjects must have a negative pregnancy test at screening (serum test) and baseline (urine test)
- Psychotherapy should not be started or changed during a patient's participation in the study. It is acceptable for a patient already receiving psychotherapy to participate in the study
- Able to speak, read, and understand sufficiently to allow completion of all study assessments
- Must provide written informed consent prior to the initiation of any protocol-specific procedures
Who cannot join
- Subjects will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied at screening (or at baseline when specified):
- Presence of an uncontrolled, unstable, clinically significant medical condition (eg, renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy) that in the opinion of the investigator could have interfered with the interpretation of safety and PK evaluations
- Presence of a clinically significant vital sign or physical examination finding that in the opinion of the investigator could potentially interfere with the ability to evaluate safety and tolerability of the trial medication or could impair the subject's ability to complete the trial
- Presence of a clinically significant abnormality on blood or urine safety tests, which do not improve on retesting. In particular, laboratory and/or clinical evidence of clinically significant hepatic conditions, such as:
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN) and total bilirubin > 2 × ULN; or
- ALT or AST > 3 × ULN with the appearance of jaundice, worsening of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia
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- Corrected QT interval, Fridericia's correction (QTcF) interval greater than 450 msec for males and 470 msec for females, or other clinically significant ECG abnormality on screening or baseline
- If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of trial medication, or is breastfeeding a child
- Uncontrolled or unstable diabetes, or a clinically significant abnormal Hba1c blood level
- Known or suspected (non-febrile) seizure disorder
- Known serological evidence of human immunodeficiency (HIV) antibody
- History of hepatitis B infection within the past year, or history of hepatitis C infection that has not been adequately treated and abnormal LFT values.
- History of neuroleptic malignant syndrome
- Current or past history of clinically significant tardive dyskinesia
- Primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment
- Known or suspected diagnosis of mental retardation or organic brain disorder
- Positive urine drug/alcohol (ethanol breathalyzer is also acceptable) screen finding, unless the positive finding can be accounted for by documented prescription use.
- Individuals who have positive results for alcohol, cannabis, or other psychotropic substances but are not dependent on or abusing these substances may be included at the investigator's discretion, following a discussion between the investigator and the medical monitor
- Heavy smoker (consumption of >40 cigarettes daily)
- Fulfillment of the DSM-5 criteria for moderate or severe substance use disorder (excluding nicotine) within the past 6 months
- Diagnosis of a psychotic disorder or a behavioral disturbance that is thought to be substance-induced or due to substance abuse
- In the investigator's opinion, at imminent risk of committing self-harm or harm to others, based on clinical interview and responses provided on the C-SSRS. Individuals will be excluded if they report having suicidal ideation of Type 4 or 5 in the past 2 months, or suicidal behavior in the past 6 months, as measured by the C-SSRS at screening or baseline
- On more than 1 antidepressant; or if on just one, a change in dose within the last 4 weeks prior to screen
- Use of depot antipsychotics within the last 6 to 9 months
- Use of electroconvulsive therapy (ECT) within the last 3 months
- Use of moderate or strong cytochrome P450 (CYP) 3A4 enzyme inducers and inhibitors (carbamazepine, phenytoin, rifampicin, phenobarbital) or moderate or strong CYP2D6 inhibitors (fluoxetine, paroxetine) (see Appendix 11.2) within 3 days or a time period of 5 half lives of the concerning drug, whichever is longer, prior to baseline
- Unwilling to discontinue any of prohibited medications prior to the baseline visit; or, in the opinion of the investigator, is unable to safely taper off such medication without significant destabilization or increased risk of self-harm (suicide). Prohibited medications may include antipsychotics, phenobarbital, fluoxetine, fluoxetine combinations, paroxetine, benzodiazepines except lorazepam, diazepam, oxazepam, psychotropics, herbal drugs/dietary supplements for depression, anxiety, insomnia, rifampicin, and quinidine
- Receipt of any investigational drugs within the last 3 months
- Current participation in any other clinical trial
- In the investigator's opinion, medically non-compliant in the management of his or her disease
- Known or suspected allergy or hypersensitivity to risperidone or any of the ISM excipients
- Previous non-responder to risperidone treatment
- Currently under involuntary in-patient commitment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hassman Research Institute
Berlin, New Jersey, 08009
Rajinder Shiwach
DeSoto, Texas, 75115
CBH Health, LLC
Gaithersburg, Maryland, 20877
Collaborative NeuroScience Research, LLC
Garden Grove, California, 92845
About this study
Official title: An Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany)
This is an Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany).
Read the detailed description
This was an open-label, 1-sequence study in patients who are were stable oral risperidone treatment. The study consisted of a screening visit, 1 treatment period with inpatient and outpatient visits, and a Follow-up visit.
Patients who were receiving existing oral risperidone treatment (4 mg) continued the oral regimen for 1 week to achieve steady-state concentrations of risperidone (Treatment A). Following the oral risperidone treatment, a single IM dose of 100 mg Risperidone ISM® was administered deeply into the gluteal muscle. A total of 4 IM doses were given, each dose separated by 4 weeks (Treatment B).
Safety assessments and PK sampling were performed once each dosing day and each outpatient visit. A final Follow-up visit was conducted to assess each patient for safety and to obtain PK samples.
Approximately 80 (with no screening failure) patients were planned for enrolment, with the intent to complete 48 patients with the assumption of an approximate drop-out/not valuable PK rate of 40%.
The primary objective of this study was to evaluate the steady-state comparative bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once-daily 4 mg oral risperidone in patients with schizophrenia stabilized on oral risperidone treatment.
The secondary objective of this study was to evaluate the safety and tolerability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once-daily 4 mg oral risperidone in patients with schizophrenia stabilized on oral risperidone treatment.
- Conditions
- Schizophrenia
- Being tested
- Risperidone ISM® 100 mg, Risperdal 4mg Tablet
- Keywords
- risperidone, schizophrenia, long-acting injectable
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone ISM® 100 mgDrug
100 mg of risperidone ISM® administered every 4 weeks
Risperdal 4mg TabletDrug
4 mg oral risperidone once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Risperidone ISM® 100 mg | Experimental | Subjects will receive 4 mg oral risperidone once daily for 7 days. After the 1 week oral risperidone regimen subjects will be administered 100 mg risperidone ISM as an injectable into the gluteal muscle. A total of 4 doses of intramuscular (IM) 100 mg risperidone ISM® will be administered deeply into the gluteal muscle. Each dose will be separated by 4 weeks. Receives: Drug: Risperidone ISM® 100 mg; Drug: Risperdal 4mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve during the dosing interval (AUCtau)
Mean steady-state area under the curve during the dosing interval for the active moiety
Measured: 28-day period following administration of the fourth dose of risperidone ISM®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start9 Mar 2021
- Primary completion17 Sep 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is an open-label, 1-sequence study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany) in subjects with schizophrenia who are on stable oral risperidone treatment. The study consists of a screening visit, 1 treatment period with inpatient and outpatient visits, and a follow-up visit.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jordi Llaudó, MD, Study chair, Laboratorios Farmacéuticos Rovi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179525
- Sponsor's protocol ID
- ROV-RISP-2020-01
- Status last verified
- Dec 2021
- First submitted
- 16 Dec 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany)
- ClinicalTrials.gov ID
- NCT05179525
- Acronym / sponsor ID
- ROV-RISP-2020-01
- Conditions
- Schizophrenia
- Keywords
- risperidone, schizophrenia, long-acting injectable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany).
Detailed description
This was an open-label, 1-sequence study in patients who are were stable oral risperidone treatment. The study consisted of a screening visit, 1 treatment period with inpatient and outpatient visits, and a Follow-up visit.
Patients who were receiving existing oral risperidone treatment (4 mg) continued the oral regimen for 1 week to achieve steady-state concentrations of risperidone (Treatment A). Following the oral risperidone treatment, a single IM dose of 100 mg Risperidone ISM® was administered deeply into the gluteal muscle. A total of 4 IM doses were given, each dose separated by 4 weeks (Treatment B).
Safety assessments and PK sampling were performed once each dosing day and each outpatient visit. A final Follow-up visit was conducted to assess each patient for safety and to obtain PK samples.
Approximately 80 (with no screening failure) patients were planned for enrolment, with the intent to complete 48 patients with the assumption of an approximate drop-out/not valuable PK rate of 40%.
The primary objective of this study was to evaluate the steady-state comparative bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once-daily 4 mg oral risperidone in patients with schizophrenia stabilized on oral risperidone treatment.
The secondary objective of this study was to evaluate the safety and tolerability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once-daily 4 mg oral risperidone in patients with schizophrenia stabilized on oral risperidone treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, 1-sequence study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany) in subjects with schizophrenia who are on stable oral risperidone treatment. The study consists of a screening visit, 1 treatment period with inpatient and outpatient visits, and a follow-up visit.
| Arm | Type | Receives |
|---|---|---|
| Risperidone ISM® 100 mg | Experimental | Drug: Risperidone ISM® 100 mg, Drug: Risperdal 4mg TabletSubjects will receive 4 mg oral risperidone once daily for 7 days. After the 1 week oral risperidone regimen subjects will be administered 100 mg risperidone ISM as an injectable into the gluteal muscle. A total of 4 doses of intramuscular (IM) 100 mg risperidone ISM® will be administered deeply into the gluteal muscle. Each dose will be separated by 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects will be considered eligible to participate in this study if each one of the following inclusion criteria is satisfied at screening (or at baseline when specified):
- Male or female aged ≥18 and <65 years with a body mass index (BMI) of ≥17 kg/m2 but ≤35 kg/m2
- Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
- Outpatient; not hospitalized for worsening of schizophrenia within the last 3 months (hospitalization for social management within this time period is acceptable)
- Medically stable over the last month and psychiatrically stable without significant symptom exacerbation over the last 3 months based on the investigator's judgement
Key exclusion criteria (33 listed)
- Subjects will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied at screening (or at baseline when specified):
- Presence of an uncontrolled, unstable, clinically significant medical condition (eg, renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy) that in the opinion of the investigator could have interfered with the interpretation of safety and PK evaluations
- Presence of a clinically significant vital sign or physical examination finding that in the opinion of the investigator could potentially interfere with the ability to evaluate safety and tolerability of the trial medication or could impair the subject's ability to complete the trial
- Presence of a clinically significant abnormality on blood or urine safety tests, which do not improve on retesting. In particular, laboratory and/or clinical evidence of clinically significant hepatic conditions, such as:
- Corrected QT interval, Fridericia's correction (QTcF) interval greater than 450 msec for males and 470 msec for females, or other clinically significant ECG abnormality on screening or baseline
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 ISM® 100 mg100 mg of risperidone ISM® administered every 4 weeks | Drug | Risperidone ISM® 100 mg |
| Risperdal 4mg Tablet4 mg oral risperidone once daily for 7 days | Drug | Risperidone ISM® 100 mg |
Primary outcome
Area under the curve during the dosing interval (AUCtau)
Time frame: 28-day period following administration of the fourth dose of risperidone ISM®
Mean steady-state area under the curve during the dosing interval for the active moiety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- 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, MD study chair
Laboratorios Farmacéuticos Rovi
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Risperidone ISM® 100 mg and Risperdal 4mg Tablet in people with Schizophrenia, run by Rovi Pharmaceuticals Laboratories at 4 sites 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 14 inclusion and 33 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 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the curve during the dosing interval (AUCtau) (time frame: 28-day period following administration of the fourth dose of risperidone ISM®). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2022.