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8 April 2024
A sponsor-initiated clinical trial with Dr. Itokawa, a researcher in the Schizophrenia Research Project, as an adviser was conducted on 97 schizophrenia patients exhibiting negative symptoms from 2017 to 2019 to evaluate the efficacy of K-163 in improvement of negative symptoms.

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A phase2 placebo-controlled study of K-163-SZ (pyridoxamine)

Dr. Itokawa, a researcher in the Schizophrenia Research Project, conducted an investigator-initiated clinical trial of K-163-SZ (pyridoxamine) on 10 patients with schizophrenia from 2011 through 2012. Subsequently, a sponsor-initiated clinical trial was conducted on 97 schizophrenia patients exhibiting negative symptoms (K-163 group: n=45, placebo group: n=52) from 2017 to 2019 to evaluate the efficacy of K-163 in improvement of negative symptoms.

We analyzed changes from baseline of the negative symptom subscale of the PANSS (Positive and Negative Syndrome Scale) and found no significant differences between the K-163 and placebo groups.

In the original investigator-initiated trial, two patients had developed Wernicke encephalitis, so in the sponsor-initiated Phase2 trial, Vitamin B1 was planned to be administered to patients who showed signs of low vitamin B1 in the blood. However, since the first patient in the Phase2 trial developed Wernicke encephalitis, the protocol was modified so that all patients took vitamin B1 throughout the trial.

Details are available in the Japanese registry of clinical trials (jRCT) linked below.

Pyridoxamine was not shown to improve negative symptoms of schizophrenia in the phase 2 clinical trial and the trial has been suspended. However, we will continue our research to elucidate the causes of schizophrenia and develop treatments.

Glossary

Placebo:
In clinical trials, patients are divided into two groups. One group is treated with the drug being tested, while the second group is treated with an inert control, referred to as a placebo. Clinical trials are performed under blind conditions where neither patients nor clinicians are informed which patients are being treated with the drug and which are being treated with the placebo.
Wernicke encephalitis:
A brain disease caused by depletion of vitamin B1. Symptoms include eye movement disorders and ataxia. This disease can be treated by administering vitamin B1.
PANSS:
The most widely-used scale for measuring the severity of schizophrenia symptoms.

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