Refractory Schizophrenia Study

Please call  1(818)696-8800  for more details.

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Summary


Condition Schizophrenia
Treatment NaBen®, oral tablet 2x/day
Phase Phase IIb/III
Status Actively recruiting
Age 18 to 55 years old
Gender All genders
Other Criteria Taking Colzapine for at least the past 6 months
Study Duration 12 weeks
Available Trial Sites US, Canada
Sponsor SyneuRx International (Taiwan) Corp.
Additional Information Link to clinicaltrial.gov

Overview

About the Study

If you, your family, or your friends have ever suffered from schizophrenia, you know that the treatment options are limited, medication effectiveness is inadequate, and side effects are common with existing therapies.

The Refractory Schizophrenia Study is one of SyneuRx’s efforts to bring new treatment options to schizophrenia patients.

It is a late (IIb/III) phase clinical study to examine and confirm the safety and effectiveness of an investigational therapy named NaBen® to improve the symptoms of schizophrenia among patients who did not respond to at least 2 drug treatments and are taking clozapine.   During this study, participants will not be taken off their current medication. NaBen® will be added to their current medication. The study is twelve (12) weeks long. During the study, participants will visit a study center six (6) times, including one (1) screening and five (5) active treatment visits. There will be one (1) follow-up phone call to conclude the study.

About the Investigational Therapy

NaBen® is an investigational therapy which is shown to enhance the glutamate-NMDA receptor function by inhibiting the degradation of D-serine by DAAO (D-amino acid oxidase). NaBen® is used as an add-on treatment to any existing drug therapies. Preliminary clinical data show that NaBen® can address comprehensive symptom domains. It can improve negative symptoms, such as social withdrawal and lack of motivation, as well as cognitive symptoms, such as concentration and memory. Currently, there is no therapy that specifically treats the negative or cognitive symptoms of schizophrenia. In addition, preliminary results show that NaBen® can supplement existing therapies to further reduce positive symptoms (for example, hallucinations, delusions, and suspiciousness) as well. The mechanism of action for NaBen® is new and different from all existing therapies.

Eligibility

Major Inclusion Criteria:

22 Adults between 18 and 55 years of age

22 Confirmed diagnosis of schizophrenia for the past 2 years

22 Prior non-response to at least 2 antipsychotic drugs

22 Taking clozapine for at least the past 6 months (dosage 200-900 mg/day, unchanged for at least the past 3 months)

22 A minimum PANSS total score of 70

22 Body Mass Index between 17 and 38

Major Exclusion Criteria:

11 Meeting the DSM-V criteria for major mental illness other than schizophrenia

11 Serious medical illness such as end-stage renal disease, liver failure, or heart failure

11 Current alcohol or drug abuse, positive drug test, or history of drug dependence in the past 6 months

Frequently Asked Questions

Am I eligible?

You are eligible if you meet the major inclusion and exclusion criteria above. Please contact us for further study screening and referral to a study center near you. (Click here)

How do I participate?

Please contact us for study screening and referral to a study center near you. (Click here)

What is the investigational therapy? How is it different?

NaBen® is an investigational therapy which is shown to enhance the glutamate-NMDA receptor function by inhibiting the degradation of D-serine by DAAO (D-amino acid oxidase). NaBen® is used as an add-on treatment to any existing drug therapies. Preliminary clinical data show that NaBen® can address comprehensive symptom domains. It can improve negative symptoms, such as social withdrawal and lack of motivation, as well as cognitive symptoms, such as concentration and memory. Currently, there is no therapy that specifically treats the negative or cognitive symptoms of schizophrenia. In addition, preliminary results show that NaBen® can supplement existing therapies to further reduce positive symptoms (for example, hallucinations, delusions, and suspiciousness) as well.

The mechanism of action for NaBen® is new and different from all existing therapies.

Is NaBen® safe? What are the side effects?

The investigational therapy NaBen® is a natural compound with an established safety profile in the past. Preliminary clinical results to date suggest that side effects are relatively minor. The doctors and nurses at the study center will monitor your safety closely.

Can the condition get worse during the study?

The doctors and nurses at the study center will monitor your conditions closely. If you experience any changes during the study, the doctors will make professional recommendations promptly.

How much will it cost?

There is no cost to participate in the study. The cost of study-related health assessments and study medication will be covered. If you need a caregiver, transportation, or assistance to come to the study site, the study center can help to arrange needed supports to reduce the barrier(s) to come to the study.

How long is the study?

The study is twelve (12) weeks long. During the study, participants will visit a study center six (6) times, including one (1) screening and five (5) active treatment visits. There will be one (1) follow-up phone call to conclude the study.

Can one pause or withdraw during the study?

Participation in the study is completely voluntary. One may refuse to participate or may withdraw from the study at any time. However, it is recommended that one adhere to the study regime and visit the study center consistently throughout the study, so long as there are no safety or other concerns.

May one switch to a different study center during the study?

Participation in the study is completely voluntary. One may refuse to participate, may switch, or may withdraw from the study at any time. However, it is recommended that one adhere to the study regime and visit the study center consistently throughout the study, so long as there are no safety or other concerns.

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Contact-Us

Please call  1(818)696-8800  for more details.