Adolescent
Schizophrenia Trial

This is a clinical trial testing NaBen as an add-on treatment to existing antipsychotics. 

Recruiting

Brain neurons in lysosomal storage diseases, Tay-Sachs, Niemann-Pick, Fabry and other. 3D illustration showing swollen neurons with lamellar inclusions due to accumulation of gangliosides in lysosomes

Summary

  • Condition
  • Treatment
  • Age
  • Gender
  • Other Criteria
  • Study Duration
  • Trial Sites
  • Additional Information
  • Schizophrenia
  • NaBen, oral tablets 2x/day
  • 12 to 17 years old
  • All genders
  • No change in medication for 2 months
  • 10 weeks
  • US, Canada, Poland, EU, Taiwan
  • Clinicaltrial.gov

Schizophrenia

NaBen, oral tablets 2x/day

12 to 17 years old

All genders

No change in medication for 2 months

10 weeks

US, Canada, Poland, EU, Taiwan

Clinicaltrial.gov

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About the Study

The Adult 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 adults between 18 and 45 years old.

During this study, participants will not be taken off their current medication. NaBen® will be added to their current medication.

The study is fourteen (14) weeks long, plus a fifty-four-week (54-week) open-label follow-up. During the study, participants will visit a study center eight (8) times, including one (1) screenings visit and seven (7) active treatment visits, followed by a 54-week open-label phase when participants will visit the study center four (4) times during the year. 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

  • Teens between 12 and 17 years of age
  • Confirmed diagnosis of schizophrenia
  • Clinically stable with residual symptoms (PANSS >=60 and SANS>=40)
  • No change in antipsychotic medication or dosage for at least the past 2 months

Major Exclusion Criteria

  • Meeting the DSM-V criteria for major mental illness other than schizophrenia
  • Currently or previously taking clozapine
  • Current alcohol or drug abuse, positive drug test, or history of drug dependence in the past 6 months
  • Body Mass Index >35

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 ten (10) weeks long. During the study, participants will visit a study center seven (7) times, including two (2) screening visits, four (4) active treatment visits, and one (1) follow-up visit 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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