Refractory
Schizophrenia Trial

This is a Phase IIb/III clinical trial testing NaBen as an add-on therapy to existing antipsychotics. 

Recruiting

Summary

  • Condition
  • Treatment
  • Age
  • Gender
  • Other Criteria
  • Study Duration
  • Trial Sites
  • Additional Information

Schizophrenia

NaBen, oral tablets 2x/day

18 to 55 years old

All genders

Taking Colzapine in the past 6 months

12 weeks

US, Canada, Poland, EU, Taiwan

Clinicaltrial.gov

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About the Study

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.

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About NaBen®

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.

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

Eligibility

Major Inclusion Criteria

  • Adults between 18 and 55 years of age
  • Confirmed diagnosis of schizophrenia for the past 2 years
  • Prior non-response to at least 2 antipsychotic drugs
  • Taking clozapine for at least the past 6 months
  • A minimum PANSS total score of 70
  • Body Mass Index between 17 and 38

Major Exclusion Criteria

  • Meeting the DSM-V criteria for major mental illness other than schizophrenia
  • Serious medical illness such as end-stage renal disease, liver failure or heart failure
  • Current alcohol or drug abuse, positive drug test, or history of drug dependence in the past 6 months

Frequently Asked Questions

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. 

Please contact us for study screening and referral to a study center near you. 

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 (MOA) for NaBen® is new and different from all existing therapies.

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.

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.

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.

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.

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.

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