Phase 2 N=66 Treatment

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

Schizophrenia · Schizo-affective Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02658357 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Feb 2020

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

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Risperidone Implant (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Braeburn Pharmaceuticals
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone	—	—
PRIMARY Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone	—	—
SECONDARY Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS)	—	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02658357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.