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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02658357
• Date of registration: 07/01/2016
• Prospective Registration: No
• Primary sponsor: Braeburn Pharmaceuticals
• Public title: Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
• Scientific title: Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
• Date of first enrolment: October 2015
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02658357
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject (and/or a subject's authorized legal representative) has provided written
informed consent

2. 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

3. Subject is male or female between 18 to 60 years of age

4. 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:

1. Hospitalized or required acute crisis intervention for symptom exacerbation in the 60
days prior to admission as determined by the Investigator

2. 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

3. 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.

4. Have impaired hepatic (ALT/AST >1.5 times higher than the upper limit of normal) or
renal function (eGFR<50 mL/min)

5. Previously defined hypersensitivity to Risperidone

6. History of neuromalignant syndrome (NMS)

7. Electroconvulsive therapy within 6 months of admission

8. Requires current use of agents that are strong inhibitors and inducers of cytochrome
P450 2D6



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Schizo-affective Disorder

Schizophrenia

Intervention(s)

Drug: Risperidone Implant

Primary Outcome(s)

Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone [Time Frame: 6 months]

Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone [Time Frame: 6 months]

Secondary Outcome(s)

Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS) [Time Frame: 12 months]

Secondary ID(s)

BB-PK-103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02658357