SchizophreniaPhase 3NCT02773576
Safety and Tolerability of Risperidone Implants
A Phase 3 study testing Risperidone implant in people with Schizophrenia, run by Braeburn Pharmaceuticals at 1 site in United States.
Trial summary
A one year, open-label, study to evaluate the safety and tolerability of risperidone implants as a maintenance treatment in patients with schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Sep 2017
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided written informed consent.
- Male and female subjects 18 to 70 years of age, inclusive, at time of informed consent.
- Subjects with a current diagnosis of schizophrenia as defined by DSM-5 criteria and a history of the illness for at least 2 years prior to screening (as per subject, family, healthcare provider, and/or by previous medical records).
- Subject is assessed by the Investigator to be symptomatically stable with regard to his or her psychiatric condition at screening and baseline.
- Subject must be stable on their current antipsychotic medication for at least 30 days prior to screening.
- Subject has identified a caregiver or personal contact with whom the subject has significant contact with at least once per week.
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- Subjects who have shown a previous response to antipsychotic treatment (other than clozapine) in the past year, according to the Investigator's opinion.
- Subjects who are currently being treated with one or two antipsychotics other than clozapine, and who, in the Investigator's judgment, require chronic treatment with an antipsychotic medication and would benefit from treatment with Risperidone Implants.
- Subjects who meet the following criteria:
- Outpatient status
- PANSS Total Score ≤ 80, and if PANSS score at baseline increases by ≥ 20% change from screening, the subject cannot participate in the study.
- PANSS scores of ≤ 4 on all of the following items:
- Conceptual disorganization
- Suspiciousness
- Hallucinatory behavior
- Unusual thought content
- Hostility
- CGI-S ≤ 4 (moderately ill)
- Lack of clinically significant suicidal ideation or behavior in Investigator's judgment
- Subjects who are able to understand the nature of the trial and follow protocol requirements, have the ability to read and understand the written word, and who can be reliably rated on assessment scales.
- Subjects who have completed adequate washout (5 half-lives unless otherwise specified) of prohibited concomitant medications, including mood stabilizers and strong inducers or inhibitors of CYP2D6 activity, prior to receiving oral risperidone or implant Risperidone.
- Subject has completed washout of 42 days for any fluoxetine containing compound.
- Female participants (if of childbearing potential and sexually active) and male participants (if sexually active with a partner of childbearing potential) who agree to use a medically acceptable and effective birth control method throughout the study.
- Subject has a body mass index (BMI) ≥18.5 and ≤38.0 kg/m2.
- Subject is assessed by the Investigator to be symptomatically stable with regard to pre-existing medical conditions as evidenced by medical history, non-clinically significant findings on physical examination, vital signs, clinical laboratory evaluations (hematology, serum chemistries, and urinalysis) or 12-lead electrocardiogram (ECG). Subjects may continue on their current prescribed medication regimens to control pre-existing medical and psychiatric conditions (other than schizophrenia) including the use of prescribed PRN medications.
Who cannot join
- Known hypersensitivity or allergy to lidocaine or any local anesthetic agent of the amide type (local anesthetic used during implant and explant procedures).
- Known sensitivity to polyurethane.
- Reports or reveals a presence of clinically significant skin disorders (such as, but not limited to, skin cancer, psoriasis, eczema, or atopic dermatitis), and/or evidence of recent sunburn, scar tissue, tattoo, open sore, body piercing or branding at the intended implantation site that would interfere with the implantation procedure or interfere with implant site assessments as determined by the Investigator.
- History of abnormal scar formation or family history of keloid formation.
- Subjects with a current DSM-5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder are excluded.
- Subjects experiencing acute depressive symptoms within the past 30 days, according to the Investigator's opinion, that required treatment with an antidepressant.
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- Subjects considered by the Investigator to be at imminent risk of suicide or injury to self, or subjects who within the past 6 months prior to Screening have attempted suicide, or who within the past 3 months prior to Screening have had active suicide ideation (positive answers to item 4 or 5 on the C-SSRS).
- Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history.
- Subjects with a history of failure to clozapine treatment or response to clozapine treatment only.
- Subjects with a documented history of failure to respond to an adequate dose of risperidone or paliperidone treatment including long acting injectable formulations.
- Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or Investigator's judgment.
- Subjects who currently meet DSM-5 criteria for substance use disorder (moderate or severe); including alcohol and benzodiazepines, but excluding caffeine, nicotine, and marijuana.
- Females who are breast-feeding or will be breast feeding during the course of the study, and/or who have a positive serum pregnancy test result prior to receiving trial medication.
- Subjects with uncontrolled hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least the past 90 days).
- Subjects who have a clinically significant history or evidence of a medical condition that would expose them to an undue risk of a significant AE or interfere with assessments of safety or efficacy during the course of the trial.
- Subjects with epilepsy or a history of seizures, except for a single childhood febrile seizure, post traumatic, alcohol withdrawal, etc. A subject with a history of any seizure activity will have their case discussed with the medical monitor prior to subject's study enrollment.
- Subjects with a positive drug screen at screening for drugs of abuse without a prescription, excluding marijuana, will be discussed with the medical monitor.
- The following laboratory test, vital sign, and ECG results are exclusionary:
- Platelets ≤ 75,000/mm3
- Hemoglobin ≤ 9 g/dL
- Neutrophils, absolute ≤ 1000/mm3
- Aspartate aminotransferase > 3x upper limit of normal
- Alanine aminotransferase > 3x upper limit of normal
- Creatinine ≥ 2 mg/dL
- Diastolic blood pressure > 105 mmHg
- QTc > 470 msec for females and QTc > 450 msec for males using the QTcF (Fridericia) correction
- Subject is HIV positive.
- Active hepatitis. Subjects with no viral load, no acute inflammation and no clinical necessity for therapy will be allowed, at the discretion of the Investigator.
- Subjects with a history of an allergic hypersensitivity to antipsychotic agents.
- Subjects with a history of significant intolerance or who are refractory to antipsychotic agents.
- Subjects with a history of neuroleptic malignant syndrome.
- Subjects with clinically significant tardive dyskinesia at screening [any one AIMS item (1-7) with a score >2].
- Subjects likely to require prohibited concomitant therapy during the trial (see Section 8.6.1).
- Subjects who require current use of agents that are strong inhibitors (e.g. quinidine) and inducers (e.g. carbamazepine, phenytoin, rifampin, and phenobarbital) of cytochrome P450 2D6.
- Subjects who have received any investigational agent in a clinical trial within 30 days prior to screening; for investigational drugs with an elimination half-life greater than 15 days, this time period will be extended to 60 days.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness, or who have ongoing legal issues that could affect their ability to continue to participate in this trial.
- Subjects who have been hospitalized, including hospitalization for psychosocial reasons, for more than 30 days total in the last 60 days prior to entry into the Screening Phase.
- Electroconvulsive therapy within 180 days prior to entry into the Screening Phase.
Trial locations and contacts
1 site in 1 country.
United States1 site
Collaborative Neuroscience Network
Garden Grove, California, 92845
About this study
Official title: A One Year, Open-label, Study to Evaluate the Safety and Tolerability of Risperidone Implants as a Maintenance Treatment in Patients With Schizophrenia
A one year, open-label, study to evaluate the safety and tolerability of risperidone implants as a maintenance treatment in patients with schizophrenia
Read the detailed description
The trial is to evaluate the 48-week safety and tolerability of risperidone implants as maintenance therapy in subjects with schizophrenia. This will be measured by the incidence of psychotic symptoms exacerbation/impending relapse, PANSS, CGI-I, CGI-S, adverse events, vital signs, clinical laboratory, physical exam and ECG findings, Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson-Angus Scale (SAS) and Investigator assessments.
- Conditions
- Schizophrenia
- Being tested
- Risperidone implant
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone implantDrug
| Study group | Role | What they receive |
|---|---|---|
| 2x360 mg risperidone implant | Experimental | 2, 360 mg risperidone implants Receives: Drug: Risperidone implant |
| 3x300 mg risperidone implant | Experimental | 3, 300 mg risperidone implants Receives: Drug: Risperidone implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed
The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.
Measured: 12 months
Secondary outcomes (1)
Incidence of Psychotic Symptom Exacerbation/Impending Relapse
The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2017
- Study completionSep 2017
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braeburn Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773576
- Sponsor's protocol ID
- BB-RSP-301
- Status last verified
- Feb 2020
- First submitted
- 11 May 2016
- Last updated
- 19 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One Year, Open-label, Study to Evaluate the Safety and Tolerability of Risperidone Implants as a Maintenance Treatment in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02773576
- Acronym / sponsor ID
- BB-RSP-301
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Braeburn PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Posted 19 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A one year, open-label, study to evaluate the safety and tolerability of risperidone implants as a maintenance treatment in patients with schizophrenia
Detailed description
The trial is to evaluate the 48-week safety and tolerability of risperidone implants as maintenance therapy in subjects with schizophrenia. This will be measured by the incidence of psychotic symptoms exacerbation/impending relapse, PANSS, CGI-I, CGI-S, adverse events, vital signs, clinical laboratory, physical exam and ECG findings, Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson-Angus Scale (SAS) and Investigator assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2x360 mg risperidone implant | Experimental | Drug: Risperidone implant2, 360 mg risperidone implants |
| 3x300 mg risperidone implant | Experimental | Drug: Risperidone implant3, 300 mg risperidone implants |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Subject has provided written informed consent.
- Male and female subjects 18 to 70 years of age, inclusive, at time of informed consent.
- Subjects with a current diagnosis of schizophrenia as defined by DSM-5 criteria and a history of the illness for at least 2 years prior to screening (as per subject, family, healthcare provider, and/or by previous medical records).
- Subject is assessed by the Investigator to be symptomatically stable with regard to his or her psychiatric condition at screening and baseline.
- Subject must be stable on their current antipsychotic medication for at least 30 days prior to screening.
Key exclusion criteria (38 listed)
- Known hypersensitivity or allergy to lidocaine or any local anesthetic agent of the amide type (local anesthetic used during implant and explant procedures).
- Known sensitivity to polyurethane.
- Reports or reveals a presence of clinically significant skin disorders (such as, but not limited to, skin cancer, psoriasis, eczema, or atopic dermatitis), and/or evidence of recent sunburn, scar tissue, tattoo, open sore, body piercing or branding at the intended implantation site that would interfere with the implantation procedure or interfere with implant site assessments as determined by the Investigator.
- History of abnormal scar formation or family history of keloid formation.
- Subjects with a current DSM-5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder are excluded.
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 implant | Drug | 2x360 mg risperidone implant, 3x300 mg risperidone implant |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed
Time frame: 12 months
The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.
1 secondary outcome
Incidence of Psychotic Symptom Exacerbation/Impending Relapse
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risperidone implant in people with Schizophrenia, run by Braeburn Pharmaceuticals 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 25 inclusion and 38 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 19 Feb 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Feb 2020). 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?
Number of Participants With Treatment-related Adverse Events as Assessed (time frame: 12 months). 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 19 Feb 2020.