Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant

NCT02658357 | Completed Phase 2 Results

• 1 other identifier: BB-PK-103
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be a 6-month, open-label, multiple center study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants.

Conditions

Schizophrenia; Schizo-affective Disorder

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone

  6 months

• Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone

  6 months

Secondary Outcomes (1)

• Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS)

  12 months

Study Arms (2)

600 mg

EXPERIMENTAL

Two, 300 mg Risperidone Implants

Drug: Risperidone Implant

900 mg

EXPERIMENTAL

Three, 300 mg Risperidone Implants

Drug: Risperidone Implant

Interventions

Risperidone Implant DRUG

600 mg; 900 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject (and/or a subject's authorized legal representative) has provided written informed consent
• Patient meets the following criteria:
• Outpatient status
• PANSS Total Score ≤ 80 at screening and if PANSS score at baseline is ≥ 20% change from screening, the patients cannot participate in the study.
• A score of ≤ 3 on the following PANSS items:
• Conceptual disorganization
• Suspiciousness
• Hallucinatory behavior
• Unusual thought content
• Subject is male or female between 18 to 60 years of age
• Subject has a diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria

You may not qualify if:

• Hospitalized or required acute crisis intervention for symptom exacerbation in the 60 days prior to admission as determined by the Investigator
• Subject has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide
• Has a current or recent (within 12 months) DSM-V diagnosis of moderate or severe substance use disorder (except for tobacco use disorder) or has a positive urine drug screen for prohibited substances at screening.
• Have impaired hepatic (ALT/AST \>1.5 times higher than the upper limit of normal) or renal function (eGFR\<50 mL/min)
• Previously defined hypersensitivity to Risperidone
• History of neuromalignant syndrome (NMS)
• Electroconvulsive therapy within 6 months of admission
• Requires current use of agents that are strong inhibitors and inducers of cytochrome P450 2D6

Sponsors & Collaborators

• Braeburn Pharmaceuticals: lead

Study Sites (1)

Segal Institute for Clinical Research 1201 North 37th Avenue

Hollywood, Florida, 33021, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

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

ckampf@braeburnrx.com

6104678728

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 18, 2016
• Study Start: October 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 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)