ADULT SCHIZOPHRENIA
SND13

The SND13 study is looking at whether a potential new medication called NaBen® is safe and effective in improving symptoms of schizophrenia in adults. The goal of this study is to increase treatment options available for schizophrenia. Due to its preliminary findings in efficacy of improving schizophrenia symptoms, NaBen® is designated as a breakthrough therapy of adjunctive treatment for schizophrenia.

Low function of the N-methyl-D-Aspartate receptor (NMDAR) subtype glutamate receptor in the brain plays an important role in the pathophysiology of schizophrenia. Enhancing NMDAR-mediated brain signaling is considered a novel treatment approach in improving schizophrenia associated symptoms. One method to enhance NMDA function is to raise the levels of D-amino acid (DAA) by reducing their metabolism via DAA oxidase (DAAO) inhibitors. NaBen® is a readily available DAAO inhibitor with a well- developed safety profile, and has received the FDA orphan product designations for the indications of schizophrenia in the pediatric population and patients with refractory schizophrenia receiving clozapine therapy. NaBen® is also designated as a breakthrough therapy in adult schizophrenia. Previous studies have shown excellent efficacy and safety for NaBen® in improving schizophrenia symptoms. This multi-center, randomized, placebo- controlled, parallel-group study is to further assess the safety and efficacy of NaBen® in improving symptoms of adult schizophrenia.

Male and Female subjects joining the study will need to visit the study center several times during a period of up to 68 weeks. There will be a total 13 visits during the 68 weeks including screening, run-in, double-blind treatment, open-label extension and follow-up phases. The study is divided in to three phases:

• Screening phase (2 weeks)
• Enrichment run-in phase (4 weeks)
• Double-blind treatment phase (8 weeks)
• Open-label extension (52 weeks)
• Follow-up phase (2 weeks)

At each visit, the study doctor will ask questions about the schizophrenia symptoms. Overall health will be monitored throughout the study using:

• Physical examinations
• Blood pressure and heart rate, EKG test
• Blood and urine test

The cost of all study-related health assessments and study medication in the study will be covered. During this study you will not be taken off your current medication. NaBen® will be added to your current treatment as an additional.

Major Inclusion criteria:

• Male or female subjects who are between 18 and 55 years of age
• Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject’s history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview. For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0)
• The subject’s schizophrenia condition is clinically stable with residual symptoms. Residual symptoms will be defined as a total score of ≤110 and ≥ 60 of PANSS per Visit 1 evaluations
• An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to screening into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for Aripiprazole and Paliperidone; six (6) months for Olanzapine pamoate monohydrate; and at least 6 times duration of the reported half life or minimum four (4) months for other depot or long-acting antipsychotics)
• Body Mass Index (BMI) between 17 and 35
• Subject has a negative routine urine illicit drug screening test

Major Exclusion criteria:

• At Screening meets the DSM criteria for major mental illness other than schizophrenia
• Subjects whose illness was resistant to antipsychotics according to prior treatments of two different antipsychotics of adequate dose
• Subjects who have been previously treated with clozapine or are currently receiving clozapine.
• Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to screening.
• The subject has previously received NaBen®
• Initiation or dose change of benzodiazepines or sleep medications, or any other psychotropic medications due to worsening of schizophrenia symptoms or medication side effects within four (4) weeks prior to screening

For more detailed information about the SND13 study, please see the US FDA clinical trial website below:

If you would like to know more about the SND13 Study, please speak with your family doctor or psychiatrist, who may refer you to the local study team using the contact information below. They will be happy to give you more information about the study and answer any of your questions.

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