Safety and Tolerability of Risperidone Implants

NCT02773576 | Completed Phase 3 Results

• 1 other identifier: BB-RSP-301
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

A one year, open-label, study to evaluate the safety and tolerability of risperidone implants as a maintenance treatment in patients with schizophrenia

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Incidence of Psychotic Symptom Exacerbation/Impending Relapse

  12 months

Other Outcomes (1)

• Change of Sleep Quality From Baseline to Month 12 Measured on the Pittsburgh Sleep Quality Index (PSQI)

  Baseline and 12 months

Study Arms (2)

2x360 mg risperidone implant

EXPERIMENTAL

2, 360 mg risperidone implants

Drug: Risperidone implant

3x300 mg risperidone implant

EXPERIMENTAL

3, 300 mg risperidone implants

Drug: Risperidone implant

Interventions

Risperidone implant DRUG

2x360 mg risperidone implant; 3x300 mg risperidone implant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Braeburn Pharmaceuticals: lead

Study Sites (1)

Collaborative Neuroscience Network

Garden Grove, California, 92845, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Christine Kampf
• Organization: Braeburn Inc

ckampf@braeburnrx.com

6104678728

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 16, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)